Helping
  • Enter New Countries
  • Build Global Alliance Network
  • Expand Distribution Channel
  • Out & In License Products
  • Access Niche, Orphan, Rare Products rights
  • Get CMO / CDMO / Tech Transfer Projects
  • Get GMP Approvals from Global Authorities
  • Create Global Quality Systems
  • Find API / FDF Suppliers
  • Third Party Vendor Quality Audits
  • Trigger EU GMP and EUQP / QPPV Audits
  • Respond Regulatory Queries
  • Get Product Registrations / MAs
  • You Succeed
for International Growth

Learn How We Catalyse your Growth ...
Knowledge & Experience

Who We Are

We are knowledge led business development experts driving international business growth through synergistic global alliances within India and internationally.

Through our expertise, key insights and specialised knowledge, we help harness promising opportunities and professionally manage entire outsourcing of products and services from India and Asia.

Using our 30+ years experience working closely with the world’s most stringent regulators, we help build compliant Quality Systems and Regulatory expertise.

Read More
Value Propositions

Service Offerings

World touch open_1232-737
Global Business Development

We open gateways for synergistic growth from international markets with the right-fit partners through:

  1. Geographical Expansion
  2. Product Portfolio Expansion
India Focus image Cropped
Profiting from India

Derive maximum advantage from India from Strategic Partnerships for:

  1. Outsourcing Products & Services
  2. JV, M&A and Stragetic partnerships
  3. Entering huge Indian market
Quality Regulatory Pic_002
Global Quality Systems

With over 30 years of experience closely working with the world’s top regulators, we help in:

  1. Undertaking Assessment
  2. Quality Compliance
  3. Obtaining Global Accreditation
    of API, FDF and CRO facilities.
Quality Regulatory Compliance 730x270 96DPI
Global Regulatory Affairs

With experience of filing 4500+ dossiers globally, we provide complete Product Dossier services right from preparation, assessment, filing, query response until grant of MA / Registration, Third Party Dossier Audits, Pre-qualification programs of Global Procurement Agencies.

Team Synergene represents a comprehensive knowledge pool of globally experienced techno-commercial experts with a proven track record spanning > 25 years in International Marketing and Business Development, Global Quality Compliance and International Regulatory Affairs that opens pathways to reach out to new geographical terrains in Finished Formulations, API, Medical and Dental Devices, Clinical & Contract Research Research and Pharma-Software domains.
Growth Enablers

What We Do

We catalyse international business growth deploying a mix of the most appropriate:

Business Models

Licensing (In & Out) | Marketing | Distribution | Technology Transfer

Geographies

India | Europe | Canada | Australasia | SE Asia | MENA | GCC | LatAm

Segments

Formulations | APIs | Medical Devices | Nutraceutical | Herbal | Clinical | Software

Product Lines

Oncology | Hormones | Peptides | MABs | NIBs | Respiratory | Ophthalmics

Global Quality and Regulatory Strategy

US FDA | EMEA | MHRA | TGA | PICS | ANVISA | WHO Geneva | GCC | CE | ISO | OHSAS
Credentials

Experience & Edge

  • Three decades of building profitable global businesses in Europe, Canada, Australia, New Zealand, Asia Pacific, MENA and India

  • Concluded over 180 commercial agreements with global clientele, obtained a multitude of GXP approvals and more than 4500 product approvals commercialized over 45 countries

  • Robust hands-on experience of greenfield facility creation, product development, Tech Transfer, dossier submission, grant of MA, regular Commercial Supply, QP, PV procedures

  • Deeply ingrained QbD knowledge with a proven track record of obtaining and maintaining global GXP / Regulatory compliances, sourcing, SCM, manufacturing, R&D, IP and cultural impact on business deliverables

  • Experienced across a wide range of products:

    • Finished dosage forms (oral solids / liquids, small / large volume Injectables, lyophilised products, Pre-filled syringes, biologicals, vaccines, oncology, hormones, insulins, penams, penicillins, cephalosporins)

    • APIs (highly potent, hormones, insulins, beta-lactam, fermentation-based)

    • Herbal / natural products, nutraceuticals, dental and medicals devices
Core Benefits

Distinct Advantage

  • Access to extensive network of key decision makers, corporate insights and deep industry knowhow

  • Knowledge of Niche / treasured assets & opportunities’ with a mindset for unlocking value from the right-fit partnerships, products and services

  • Creating profits partnering with India’s most treasured life science resources and promising opportunities, reducing risks and shortening turnaround times

  • Hands-on experience of mobilizing the most apt resources and solutions with robust execution to create faster pathways and better business outcomes

  • Building transparent collaborative partnerships with highest levels of trust, integrity and business sustainability

  • Having access to knowledgeable teams with proven methodology to challenge traditional thinking and driving transformation for unlocking market synergies

  • Ground-level-experts-led engagements to sharpen team skills on regulatory, commercial and business aspects

Helping
  • Enter New Countries
  • Build Global Alliance Network
  • Expand Distribution Channel
  • Out & In License Products
  • Access Niche, Orphan, Rare Products rights
  • Get CMO / CDMO / Tech Transfer Projects
  • Get GMP Approvals from Global Authorities
  • Create Global Quality Systems
  • Find API / FDF Suppliers
  • Third Party Vendor Quality Audits
  • Trigger EU GMP and EUQP / QPPV Audits
  • Respond Regulatory Queries
  • Get Product Registrations / MAs
  • You Succeed
for International Growth

Learn How We Catalyse your Growth ...

Enhancing Business Value

We catalyse International Business Growth by: 

  • Expanding International Business Network
  • Enhancing Global Quality & Regulatory competence 
  • Multiplying profits from Indian Outsourcing & Market Access.

Enhancing Business Value

We catalyse business growth by: 

  • Expanding international business network
  • Enhancing Quality & Regulatory competence 
  • Multiplying profits from Indian Outsourcing & Market Access.

  • आपका हार्दिक स्वागत है

    Cordial Welcome

    Synergene catalyses swift international business growth by expanding Global network, enhancing Quality & Regulatory capabilities and multiplying profits from Indian Outsourcing & Market Access.

    Explore more

    Synergene catalyses swift international business growth by expanding Global network, enhancing Quality & Regulatory capabilities and multiplying profits from Indian Outsourcing & Market Access.

    Explore more

  • Opening Gateways

    For Global Business

    Driving knowledge based international growth by expanding global network and product portfolio expansion.

    Details

    Driving knowledge based international growth by expanding global network and product portfolio expansion.

    Details

  • Building Competence

    For Global Compliance

    Sharpening Global Quality & Regulatory edge and strengthening knowledge quotient for opening-up global business possibilities.

    Details

    Sharpening Global Quality & Regulatory edge and strengthening knowledge quotient for opening-up global business possibilities.

    Details

  • Unlocking India

    For Growth & Profits

    Facilitating strategic growth partnerships for gaining advantage from India's global prominence and edge in Pharma and Lifesciences domain.

    Details

    Facilitating strategic growth partnerships for gaining advantage from India's global prominence and edge in Pharma and Lifesciences domain.

    Details

Helping
  • Enter New Countries
  • Build Global Alliance Network
  • Expand Distribution Channel
  • Out & In License Products
  • Access Niche, Orphan, Rare Products rights
  • Get CMO / CDMO / Tech Transfer Projects
  • Get GMP Approvals from Global Authorities
  • Create Global Quality Systems
  • Find API / FDF Suppliers
  • Third Party Vendor Quality Audits
  • Trigger EU GMP and EUQP / QPPV Audits
  • Respond Regulatory Queries
  • Get Product Registrations / MAs
  • You Succeed
for International Growth

Learn How We Catalyse your Growth ...

Helping
  • Enter New Countries
  • Build Global Alliance Network
  • Expand Distribution Channel
  • Out & In License Products
  • Access Niche, Orphan, Rare Products rights
  • Get CMO / CDMO / Tech Transfer Projects
  • Get GMP Approvals from Global Authorities
  • Create Global Quality Systems
  • Find API / FDF Suppliers
  • Third Party Vendor Quality Audits
  • Trigger EU GMP and EUQP / QPPV Audits
  • Respond Regulatory Queries
  • Get Product Registrations / MAs
  • You Succeed
for International Growth

Click to know more about Our Service Offerings...

Global Business Development

We pave synergistic growth through entry in new international markets with the right-fit partners from: Geographical & Product Portfolio Expansion
Learn more

Global Quality Systems

With over 30 years of experience closely working with the world’s top regulators, we help in Assessment, Compliance and getting Global Accreditation of facilities.
Learn more
India Focus image Cropped

Profiting from India

Derive maximum advantage from India from Strategic Partnerships for: Outsourcing Products & Services, JV or M&A, Entering huge Indian market.
Learn more

Global Regulatory Affairs

Complete Dossier services until grant of MA / Registration, Third Party Dossier Audits, Pre-qualification programs of Int'l Procurement Agencies.
Learn more
Domain Experts

Meet The Team

Manish Badonia

Founder & Managing Director

Manish founded Synergene Global bringing in over 25 years of techno-commercial Global Business Development experience.

Dr. Arvind K Mishra

Co-founder & Technical Director

Dr. Mishra is an industry veteran bringing in over 3 decades of Global experience in Technical, Quality and Regulatory Strategy.

Manish Badonia

Manish Badonia

Founder & Managing Director

Manish is an experienced techno-commercial business development professional bringing in 25+ years experience garnered with top companies. He has extensively travelled > 30 countries sharpening his core expertise in spotting & transforming opportunities into profitable global businesses, deploying right-fit partners, business models, products & geographies.

Dr. Arvind Mishra

Dr. Arvind Mishra

Co-Founder & Technical Director

Dr. Mishra is an industry veteran with over three decades of robust experience in global quality, regulatory and strategy. As a highly accomplished leader, he drives Technical, GMP & Regulatory Projects in Quality Control, Quality Assurance, Manufacturing, Regulatory Affairs, R&D & Clinical Research in APIs, FDFs, Biologicals and Medical Devices.

MB Photo IMG_5193-4x6
+91 94266 49896
Manish Badonia
Founder & Managing Director

Manish brings in over 25 years of techno-commercial Global Business Development experience.

AKM Dr
+91 90990 99264
Dr. A. K. Mishra
Co-Founder & Technical Director

Dr. Mishra is an industry veteran with >3 decades Global experience in Technical, Quality & Regulatory.

Services Portfolio

International Business Expansion

We undertake end-to-end services for expanding business internationally including Commercial Business Development, Quality Approvals of Facilities and Product Registrations / Marketing Authorizations.

Profiting from India

We help your Maximize Profits from India - be it from Outsourcing products or services, forging high-value Strategic Alliances / Acquisitions or Opening up huge Indian Market for your offerings with the most apt partners and channels.

GLOBAL Business Development

Using our > 25 years global building business experience, our core focus is evolving synergies with the right mindset international partners for driving sustainable growth. With our deep domain knowledge and insights, we deliver multiple avenues of growth from new countries / new partners and new products.

Help grow Geographically with strong best-fit Alliance Partners for Licensing-out / distribution of Products / Technologies in new countries or regions:

  • HIGHLY REGULATED Territories in US, EU, Canada, AU/NZ, BR, ZA
  • HIGH GROWTH EMERGING Territories in SE Asia, Middle East, Africa, Latin America
  • INDIA – Unlocking a huge high potential market

For incremental revenues, we help you get access to New Differentiated Products (in-licensing, Technology Transfer or Distribution rights)  in your portfolio:

  • Speciality Rx Products [Oncology, Hormones, Ophthalmics, Respiratory MDI/DPI, Liposomal, Niche Injectables, MABs, NIBs, Suppositories], Orphan Drugs, 505 (b) (2) and Para IV filings
  • Differentiated OTC or Food Supplements
  • Differentiated Medical Device

Outsourcing with India Edge

We help you derive maximum advantage from India's global edge and prominence in Pharmaceuticals, Medical Devices and Healthcare by facilitating strategic growth partnerships.

Efficiently Build & Manage Outsourcing Alliances

We facilitate efficient sourcing of low-cost high-quality Products & Services. We deeply understand India, its corporate culture and have accumulated knowledge of a lot of ‘hidden gem’ highly competent companies that are below the line of sight and routine radars. With our deep domain knowledge, trusted network, internal insights and ground knowhow of local nuances, we help forge alliances with the most promising right-mindset business partners for CMO/CDMO/CRO or standalone services.

We have garnered extensive ground level experience being integral part of large global Indian companies and successfully delivered numerous projects working with diverse global / western companies of varied sizes, geographical origin & focus which sharpened our understanding of each side’s mindset and expectations. This unique dual-side experience allows us to successfully bridge the gap tweaking alignment between Indian deliverables and western expectations. This unleashes truly profitable business value and avoids expensive pitfalls that can render projects non-competitive or unviable (seriously affecting timeliness, quality and costs) and difficult to correct.

  • Contract Manufacturing [CMO] / Site Transfers – FDF and API change
  • Licensing-In [Products & Technologies]
    • Special Rx Products [Oncology, Hormones, Respiratory MDI/DPI, Liposomal, Niche Injectables, MABs, NIBs, Suppositories], Orphan Drugs
    • Differentiated OTC, OTX or Food Supplements
    • Differentiated Medical Device
  • Contract R&D [CDMO] for Development / Stability Studies / Analytical Development
  • Clinical Research [CRO] & Bioequivalance Studies
  • Regulatory Support [Dossiers / Expert Reports / Pharmacovigilance]
  • End-to-End Project Tracking: From R&D / Development & Registration until Launch
  • API Sourcing
  • Development of alternate API Sources
  • Contract R&D [CDMO] for API Development / Stability Studies / Analytical Development
  • Regulatory Support [DMF / Site Master Files]
  • End-to-End Project Tracking: From R&D / Development to  Registration until Commercial Supplies

Managing, De-bottlenecking and Optimising Vendor deliveries to ensure better performance metrics (KPIs):

  • On-Time Deliveries (OTD)
  • Client-Service Levels (CSLM)
  • Optimisation of Logistics Cost

For your existing or potential Vendor or Supplier of Finished Dosages or API, we undertake Third Party Audits in India, Asian Countries & Japan for:

  • Manufacturing Site
  • Clinical Facility
  • Registration Dossier

DISCOVER:

Our collective 50+ years industry-insider experience and network has helped us accumulate rare insights for spotting ‘HIDDEN-RARE-GEMS’ (highly competent but not so well known publicly) for Joint Venture or Acquisition imparting competitive edge to your business.

EVALUATE:

We help undertake Technical and Commercial due diligence of such right-fit complementary skillset companies.

ACCESS:

We undertake entire activity set right from identification to evaluation until completion of deals to uncover real value.

India | Outsourcing for Competetive Edge

We help derive maximum advantage from India's global edge and prominence in Pharmaceuticals, Medical Devices and Healthcare by facilitating strategic growth partnerships. Our niche knowledge of highly competent 'hidden gems' and relationships with key stakeholders translates into a big difference in outcomes.

Efficiently Build and Manage Outsourcing Alliances

We deeply understand India, local industry, its corporate culture and have accumulated knowhow of highly competent ‘hidden gem’ companies operating below the line of sight and routine radars. With our deep domain knowledge, trusted network and insights, we help forge alliances with the most promising right-mindset business partners for CMO/CDMO/CRO or standalone services.

We have garnered extensive ground level experience being integral part of large global Indian companies and successfully delivered numerous projects working with diverse global / western companies of varied sizes, geographical origin & focus which sharpened our understanding of each side’s mindset and expectations. This unique dual-side (Indian and Western) experience allows us to successfully bridge the gap and tweak alignment between Indian deliverables and western expectations. This unleashes truly profitable business value and avoids expensive pitfalls that can render projects non-competitive or unviable (seriously affecting timeliness, quality and costs) and difficult to correct.

Significant Outcomes Improvement with Local Presence:

We undertake deep assessment and gather pertinent information for identification of issues and suggest most pragmatic and impactful solutions facilitating informed decision making and ensuring effective implementation.

End-objectives:

  • As your local eyes and ears, we provide deep insights and information on-ground competition, pricing, technical issues and supply chain issues. distribution channels etc.
  • Streamline operations by resolving bottlenecks in  Development, Manufacturing, Supply Chain etc.
  • Seeking opportunities for enhancing revenues and profitability by finding new profitable partnerships and improved COGs
  • Diversifying in new products or value-added services most helpful for gaining momentum
  • Rapidly reducing supply risk by finding best-fit alternate / 2nd / 3rd source of API / FDF

Activities:

  • Sourcing of API’s, Formulations and Intermediates from India
  • Identification & selection of Supplier / Partner for CMO, CDMO, offshore R&D Lab for CRAMS, Clinical Trials etc.
  • Evaluate suppliers based consistency, efficiency, economy and extensive audits of quality systems / GMP compliance
  • In-Licensing / getting Distribution or Marketing rights of Products in International Markets
  • Audit of dossiers for completeness and compliance with requisite regulations
  • Project Management for setting up Greenfield/Brownfield Facility

Segment-wise value added activities:

  • Contract Manufacturing [CMO] / Site Transfer | FDF & API change
  • Licensing-In and Technology Transfer
    • Speciality Rx Products / Orphan Drugs / 505 (b) (2) and Para IV filings [Oncology, Hormones, Ophthalmics, Respiratory MDI/DPI, Liposomal, Niche Injectables, MABs, NIBs, Suppositories, PFS]
    • Differentiated OTC, OTX, Herbal or Food Supplements
    • Differentiated Medical Device & DIagnostics
  • API Sourcing
  • Development of alternate API Sources
  • Contract R&D [CDMO] for API Development / Stability Studies / Analytical Development
  • Regulatory Support [DMF / Site Master Files]
  • End-to-End Project Tracking: From R&D / Development to  Registration until Commercial Supplies

Managing, De-bottlenecking and Optimising Vendor deliveries to ensure better performance metrics (KPIs):

  • On-Time Deliveries (OTD)
  • Client-Service Levels (CSLM)
  • Optimisation of Logistics Cost

For your existing or potential Vendor or Supplier of Finished Dosages or API, we undertake Third Party Audits in India, Asian Countries & Japan for:

  • Manufacturing Site
  • Clinical Facility
  • Registration Dossier
  • Contract R&D [CDMO] for full scale Development or standalone services for Stability Studies / Analytical etc. Development
  • Clinical Research [CRO] & Bioequivalence Studies
  • Regulatory Support [Dossiers / Expert Reports / Pharmacovigilance]
  • End-to-End Project Tracking: R&D / Development,  Registration till Launch


Flexible Options to establish Indian Presence:

ESTABLISHING ‘VIRTUAL’ INDIAN OFFICE

Get the advantage of your own presence by establishing ‘VIRTUAL’ Plug-N-Play Indian office without spending significant time and capital resources on creating legal entity. Quick start Indian outsourcing affairs in just weeks avoiding unnecessary hassles and initial business setup costs. Operations managed by highly experienced industry professionals who understand not only the pharma regulatory aspects, but are well versed with local business culture,  operational realities, nuances and industry insights to ensure better supplier relationships.  Manage your day-to-day operations with your suppliers / business partners for delivering better returns in both time and investment terms.

  • Plug-and-Play operations fully aligned and in-sync with your corporate team and running seamlessly as per your corporate guidelines
  • Highly experienced  and qualified industry professionals managing agreed scope of operations ranging from Purchase to Supply Chain, Regulatory Filings to Artworks or Project Management, Product Development Projects, Third Party Audits etc.
  • No need to bother about Payroll, HR, Expenses, Travel Management etc.
  • Quick, Hassle free and Cost effective & with Lowest Exposure to risk
  • Huge savings on Time & management Resources with no fixed investments or setup costs
  • Fully equipped manpower with laptop / computer stations, printers & mobile / telephones, power backup and high-speed internet with video conferencing facilities etc.
  • Bypass red tape  / formalities of establishing legal entity by avoiding the hassles of office setup

ESTABLISHING ‘FULLY MANAGED’ INDIAN REPRESENTATIVE OFFSHORE OFFICE

Get your own Local Entity with Managed Indian Office, without spending time running from pillar to post to establish everything from ground zero. You get complete administrative backend support not just for establishing your local entity but also managing a fully functional office, seamlessly integrated & operational as per your corporate guidelines. This allows you to completely focus on key activity of driving sales and developing your business.

  • Setting up an India office with licenses, compliances, manpower, workstations and connectivity

  • Choosing right from Office Location to Company Incorporation, obtaining requisite  Registrations and Approvals from Regulatory Bodies like RBI, Drugs Controller of India, DCI/CDSCO) for Drugs / Medical Devices,  Goods & Service Tax (GST) Number, Income Tax  (TAN/PAN) Number, Local Municipal Approvals, Import-Export Code (IEC Number) etc.

  • Offshore Manpower (fully aligned and operating seamlessly with your corporate team as per your corporate guidelines) for managing activities from Purchase to Supply Chain, Regulatory Filings to Artworks or Project Management, Product Development Projects, Third Party Audits etc.

  • Managed Employee Onboarding & Exit, Expenses reimbursement, Accounting, Payrolls, Tax & Compliance

  • Full Office Infrastructure with IT & Administrative support (payments, work visas, travel bookings)

INDIA | STRATEGIC JV or ACQUISITION

India has a large number of manufacturing companies and choosing the right partner that provides maximum value and strategic fit is very crucial. Many global companies have set-up their base in India for supplies to their global markets. With first hand deep domain experience we help you get maximum advantage from India by connecting with promising JV/Acquisition targets / partners that possess desired complementary skillsets and facilitate strategic growth.

DISCOVER

Our collective 50+ years industry-insider experience and network has helped us accumulate rare insights for spotting ‘HIDDEN-RARE-GEMS’ (highly competent but less known publicly) for Joint Venture or Acquisition imparting competitive edge to your business.

EVALUATE

We help you undertake Technical and Commercial due diligence of potential target companies for evaluation of their complementary skillsets and value unlocking.

ACCESS

We undertake entire activity set right from identification to evaluation until completion of deals to uncover real value.

India | Unlocking Huge Market

India is amongst world's fastest growing large economies with a huge population nearly twice that of all European countries combined. The domestic pharmaceutical market estimated at US$ 42 billion in 2021 is expected to grow 3x in the next decade. India's medical devices market stood at US$ 10.36 billion in FY20 growing at a CAGR of 37% and expected to reach US$ 50 billion by 2025.

A Huge Market capable of Transforming Business

India is a huge market that can rapidly transform the fortunes of any company. Understanding its potential, a large number of companies from across the globe are operating in India since several decades.

The market is characterised by huge volumes but is highly price sensitive, highly fragmented and operates in stark contrasts in many ways as compared to Western organized markets. Customer accessibility is the key driver and heavily hinges on the right choice of partnerships and entry plan. 

We help connect with the most potential right mindset emerging companies that are flexible, poised for rapid transformation, have strong management team and established sales force that enjoys strong rapport with the target customers.

Partnerships for India Market Entry / Access

  • Market Research & India market entry strategy
  • Identifying and selecting the right partner for:
    • Out-Licensing of Products
    • JVs/Acquisitions
    • Manufacturer / Co-Development  / Co-Marketing Partner
    • Importer-distributors
  • Help obtain necessary license and permits depending on the chosen model of entry.
  • Executive search for top positions

GLOBAL QUALITY SYSTEMS

With over 30 years of robust track record of working closely with the world’s top-notch regulatory agencies in obtaining and maintaining global GXP compliance, we impart expert guidance in Assessment, Compliance & Global Accreditation of FDF, API Manufacturing & Clinical facilities, opening-up new frontiers for business growth.

Taking Quality to the Next Global Level

With our deeply engrained QbD knowledge base, we impart expert guidance for GMP/GLP/GCP/GDP compliance.

  • Extensively worked on hands-on basis, right from greenfield facility creation to product development to Tech Transfer to regulatory dossier compilation, running regulatory approval procedures till grant of MA, and full scale regular Commercial Manufacturing and Supply.
  • Highly experienced in a wide range of Finished Dosage Forms (Oral Solids/Liquids to small & large volume Injectables, Lyophilised products, Pre-filled syringes, Biologicals & Vaccines, Oncology, Hormones, Insulins, Penicillins, Cephalosporins), APIs (highly potent, Hormones, Insulins, Penicillins, Cephalosporins), Herbal and Nutraceuticals, Medicals Devices, Diagnostics & Disposables.

Our services include the following (both within India & Overseas): 

1. Establishing NEW GREENFIELD MANUFACTURING FACILITY
2. RENOVATIONS of existing facilities to facilitate Global GMP APPROVALS

  • Full-scale GAP Analysis for Quality Management System (QMS) improvement
  • Implement Quality Risk Management and Validation Programmes
  • Perform GMP Pre-audit of Manufacturing facilities, R&D Labs and BE Centre
  • Help improve Document Management System (DMS)
  • Help improve QC Laboratories functioning
  • Validation of Utilities (HVAC, Water, Nitrogen and Compressed Air Systems)
  • Help improve Equipment Qualification and Verification procedures
  • Validation of Microbiological Methods
  • Help implement Software Systems in QC Lab, QA, R&D and other operations
  • Existing Software Validations (SAP, LIMS, TrackWise)

4. Perform THIRD PARTY VENDOR FACILITY AUDITS

5. Arranging European Qualified Person (QP) Audits

6. Participate in International (Regulatory) AUDITS

7.Assist in preparing AUDIT COMPLIANCE RESPONSES (FD 483, FDA Warning Letters) 

8. EMPLOYEE TRAINING for knowledge improvement & sharpening skills

9. Help IMPROVE PRODUCTIVITY and provide suggestions to reduce Cost

 
Offering services in the following areas:
  1. We undertake RENOVATION / TRANSFORMATION of existing manufacturing facilities to make them compliant as per desired Regulatory authority’s norms.
  2. Arranging for European Qualified Person / QP Audit
  3. We facilitate INTERNATIONAL GMP APPROVALS of Indian or Overseas Formulations (Oral and Injectables) manufacturing facilities:
  • US-FDA / EU-GMP / UK-MHRA / AU-TGA
  • WHO-Geneva
  • ZA-SAHPRA / BR-ANVISA / GCC
  • PIC/s countries

We undertake for existing or potential Vendor / Supplier, Independent Third Party Audits:

  1. GEOGRAPHIES: India, Asian Countries & Japan 
  2. PRODUCT TYPES: Finished Dosages or API
  3. AUDIT SCOPE could include:
  • Manufacturing Site
  • Clinical Facility
  • Registration Dossier

We also arrange for European Qualified Person / QP Audit

We undertake complete end-to-end solutions (right from Concept to Commissioning) for creation of NEW GREENFIELD MANUFACTURING FACILITY: 

  • For Formulations or APIs
  • In India or Overseas

Our Technical Team: We have a highly experienced 10 member technical team with hands-on experience and expertise in areas of QC/QA, Engineering, Production, Project management and Regulatory affairs to supervise and execute such projects.

Post audit of your facility, we provide assistance in  preparing International AUDIT COMPLIANCE RESPONSES (FD 483, FDA Warning Letters).

  • We impart EMPLOYEE TRAINING to your facility staff for knowledge up-gradation on GMP and regulatory guidance documents
  • Help IMPROVE PRODUCTIVITY and provide suggestions to Reduce Energy Cost and Wastage
  • We provide  practical suggestions related to PRODUCT DEVELOPMENT and TECHNOLOGY TRANSFER

GLOBAL REGULATORY AFFAIRS

Over 30 years, we have undertaken global submissions and obtained more than 3600 Marketing Authorizations (MA) / Registrations in various countries from the most regulated ones to emerging countries. We are well versed with different class of products and multiple types of regulatory documentation submissions IND, ANDA, CTD, ACTD, DMF, SMF etc. and running various regulatory procedures.

Proactive Regulatory Affairs to support Business Growth

We help strengthen and sharpen regulatory skills that opens faster pathways to support  International Business Growth.

Our services include the following: 

  • Documentation / Dossier Preparation, Review and Advisory for RA Compliance
  • Preparation of DMFs (CTD), IND, ANDAs (CTD, ACTD ) for US and other Regulated Markets
  • Review of Dossiers for their correctness and completeness
  • Product Registration Dossiers for ROW Market
  • Prepare query responses on submitted dossier
  • Obtaining MA using the most suitable regulatory pathway
  • Dossier Audit of Vendor for  Completion & Compliance
  • Pre-qualification program for WHO Geneva & other International Procurement Agencies

We are knowledge led business development experts driving international business growth through synergistic global alliances within India and internationally.

Through our expertise, key insights and specialised knowledge, we help harness promising opportunities and professionally manage entire outsourcing of products and services from India and Asia.

Using our 30+ years experience working closely with the world’s most stringent regulators, we help build compliant Quality Systems and Regulatory expertise.

Read More
Value Propositions

Service Offerings

Global Business Development

We pave synergistic growth through entry in new international markets with the right-fit partners from: Geographical Expansion Product Portfolio Expansion
Learn more

Global Quality Systems

With over 30 years of experience with the world’s top regulators, we help in Assessment, Compliance & Global Accreditation of Facilities.
Learn more

Profiting from India

Derive maximum advantage from India from Strategic Partnerships for: Outsourcing Products & Services, JV or M&A, Entering huge Indian market
Learn more

Global Regulatory Affairs

Complete Dossier services until grant of MA / Registration, Third Party Dossier Audits, Pre-qualification programs of International Procurement Agencies.
Learn more
Domain Experts

Meet The Team

+91 94266 49896
Manish Badonia
Founder & Managing Director

Manish brings in over 25 years of techno-commercial Global Business Development experience.

+91 90990 98264
Dr. A K Mishra
Co-Founder & Technical Director

Dr. Mishra is an industry veteran with >3 decades Global experience in Technical, Quality & Regulatory.

Manish Badonia

Manish Badonia

Founder & Managing Director

Manish is an experienced techno-commercial business development professional bringing in 25+ years experience garnered with top companies. He has extensively travelled > 30 countries sharpening his core expertise in spotting & transforming opportunities into profitable global businesses, deploying right-fit partners, business models, products & geographies.

Dr. Arvind Mishra

Dr. Arvind Mishra

Co-Founder & Technical Director

Dr. Mishra is an industry veteran with over three decades of robust experience in global quality, regulatory and strategy. As a highly accomplished leader, he drives Technical, GMP & Regulatory Projects in Quality Control, Quality Assurance, Manufacturing, Regulatory Affairs, R&D & Clinical Research in APIs, FDFs, Biologicals and Medical Devices.

Manish Badonia

Manish Badonia

Managing Director

Manish is an experienced techno-commercial business development professional bringing in 25+ years experience garnered from travel in 40+ countries. His core expertise is spotting & transforming opportunities into highly profitable global businesses, deploying the right-fit mix of partners, business models, products and geographies.

Manish Badonia

Manish Badonia

Managing Director

Manish is an experienced techno-commercial business development professional bringing in 25+ years experience garnered from travel in 40+ countries. His core expertise is spotting & transforming opportunities into highly profitable global businesses, deploying the right-fit mix of partners, business models, products and geographies.

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Jacobs Welly
Chief Executive Officer
Lily Peterson
Managing Director
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Manish Badonia

Manish Badonia

Managing Director

Manish is an experienced techno-commercial business development professional bringing in 25+ years experience garnered from travel in 40+ countries. His core expertise is spotting & transforming opportunities into highly profitable global businesses, deploying the right-fit mix of partners, business models, products and geographies.

Manish Badonia

Managing Director

Manish Badonia

Managing Director

Manish is an experienced techno-commercial business development professional bringing in 25+ years experience garnered from travel in 40+ countries. His core expertise is spotting & transforming opportunities into highly profitable global businesses, deploying the right-fit mix of partners, business models, products and geographies.

About Us

We are knowledge led business development experts, focussed on driving international business growth through synergistic global alliances within India and internationally.

Through our expertise, key insights and specialised knowledge, we help harness promising opportunities and professionally manage entire outsourcing of products and services from India and Asia.

Using our 30+ years experience working closely with the world’s most stringent regulators, we help build compliant Quality Systems and Regulatory expertise.

 
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Value Propositions

Service Offerings

About Us

We are knowledge led business development experts, focussed on driving international business growth through synergistic global alliances within India and internationally.

Through our expertise, key insights and specialised knowledge, we help harness promising opportunities and professionally manage entire outsourcing of products and services from India and Asia.

Using our 30+ years experience working closely with the world’s most stringent regulators, we help build compliant Quality Systems and Regulatory expertise.

 
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Transparency

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Experience

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Integrity

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Global

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Strategy and Planning

We bring the right people together to challenge established thinking and drive transform in 2020

Strategy and Planning

We bring the right people together to challenge established thinking and drive transform in 2020

Strategy and Planning

We bring the right people together to challenge established thinking and drive transform in 2020
  • Building transparent partnerships through trust and integrity
  • Sharpen inhouse competence expert led engagements on all regulatory, commercial and business aspects.

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Inherent

Transparency

Time has changed

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Growth Enablers

Integrity

Growth Enablers

Quality
Value Propositions

Service Offerings

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Innovation

We are persistently exploring new thoughts, ideas and perspectives for adding value to business.

Quality

Quality is deeply ingrained in our mindset an omnipresent quintessential habit of our lives and work.

Trust

Trust is our vital, indispensable and ubiquitous driving force that we consider quintessential for business.

Speed

We remain totally committed to swiftly delivering planned objectives and agreed promises.

Integrity

Integrity is natural and our absolute business trait. We are committed to 'Talk your Thought, Walk your Talk'.

Transparency

Reflecting our total commitment to trust and transparency, we directly connect business partners.

Unique Elements and widgets

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