Syner-G Pharma CMC Consulting, LLC Information

Syner-G Pharma CMC Consulting, LLC is a Boston based consulting firm specializing in providing full spectrum of customized CMC Regulatory, Project Management and QA/cGMP services for Bio-Pharmaceutical companies. 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. We fully recognize that each client and each project is unique and the CMC requirements vary depending on several factors such as complexity of the molecule, formulation, indication, patient population and stage of development.  With patient safety and regulatory compliance as the primary objectives, Syner-G helps to design and implement science and risk-based, phase-appropriate CMC solutions to expeditiously advance your drug during development and/or sustain the commercial supply chain post-approval.  Our CMC-360 business units operate in an integrated fashion to ensure that that the solutions we provide fully conform to the scientific standards and regulatory requirements