Quality & Compliance

Ensuring the Highest Quality

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.

Quality & Compliance Consulting

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.

Our 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
Our Focus:

At Syner-G Pharma Consulting, Chemistry, Manufacturing and Controls (CMC) is our sole focus. We offer a complete suite of CMC solutions (CMC-360) in the following three core areas: Regulatory Affairs, Pharmaceutical Development, and QA/cGMP Compliance.

Contact Us:

Syner-G Pharma Consulting, LLC
371 Turnpike Road
2 Park Central Drive, Suite #110
Southborough, MA 01772
(508) 460-9700

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