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Quality Systems Assessment & Improvement

Gain from Team Synergene’s Quality Systems Complaince Advisory emanating from extensive experience of working closely with world's most stringent regulators.

Global Quality Systems Assessment

We help you to get in-depth understanding of current risk-based complaince levels of your site or your vendor's site ... 

  • GAP Analysis and Improvement Plan
  • Documentation [Batch Record/Validation / APR] and SOP Review
  • Improvement in Documentation Management System, QC Lab / QA
  • Quality Risk Management Policies and Procedures
  • Preparation (Pre-audit) of Manufacturing facilities, R&D Labs, BE Centre
  • Assist in preparing International audit compliance responses (FD 483, FDA Warning Letters etc.)

 

GxP Compliance Readiness Advisory

Gain from our knowhow for obtaining following regulatory accreditations for your site with QbD approach.

  • Regulatory Accreditations from across the Globe
  • US FDA / EMEA / MHRA / TGA / PIC/S / ANVISA / GCC / MCC / WHO Geneva
  • CE, ISO and OHSAS Conformity Certifications

 

  • Covering a large range of Product Types
  • Finished Dosage Forms - Sterile & Non-sterile, Penicillins, Cephalosporins, Oncology, Hormonal, High Potency, Biosimilars
  • APIs and Intermediates
  • Medical Devices, Diagnostics and Disposables