Syner-G provides QA/cGMP consulting services such as setting up Quality Systems, conducting GMP audits, batch record review, GMP batch release and support for pre-approval inspections (PAI). Our experienced QA/cGMP consultants can help you ensure cGMP compliance for clinical or commercial supplies in concert with our CMC regulatory or development offerings, or as a stand-alone service.
Our Quality and Compliance Consulting services include:
- Design and implementation of GMP Quality Systems
- GMP audits / GMP Training
- GMP Documentation review
- PAI-readiness assessment/Support
- CMO Oversight (person-in-the-plant)
- GMP investigations and deviation reports
- Product complaints and product recalls
Frequently, cGMP compliance issues are triggered by nonconformance to regulatory commitments. Syner-G offers gap analyses and remediation plans to address such CMC compliance issues. In addition, Syner-G offers expert and innovative solutions to address quality issues through science and risk-based approaches. Such applications are frequently needed to manage change-control activities during development and post-approval stages.
Syner-G also provides science and risk based approaches to defend pre-approval inspection (PAI) issues.