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.
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.)
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