Quality | Assurance, Accreditation & Compliance

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
Connect For Growth Opportunities

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