Syner-G Pharma CMC Consulting | Quality and Compliance
16315
page,page-id-16315,page-template,page-template-full_width,page-template-full_width-php,ajax_updown_fade,page_not_loaded,boxed,,qode-theme-ver-6.0,wpb-js-composer js-comp-ver-4.12,vc_responsive

Quality and Compliance

header-compliance

Compliance by Design...
…throughout Product Life-Cycle

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.

HOW CAN WE  HELP YOU?

Contact Us