Detail 1
HIGH Quality GUARANTY
ElynMax 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
Detail 2
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
Detail 3
We are ready to be a seamless extension of your organization to fill your CMC needs and offer customized CMC solutions to expedite the drug development with maximum flexibility and efficiency without compromising quality and patient safety. We have designed our organization with three core business units that offer a full suite of CMC services in the areas of CMC Regulatory Affairs, Pharmaceutical Development, and QA/cGMP Compliance (CMC-360 ) with a flexible and adaptive models of talent utilization and pricing.