To enable our clients to achieve their missions of bringing life saving & life-enhancing products to patients.
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.
Proven Strategic Solutions for all your CMC Challenges
Syner-G specializes in offering CMC development consultation for virtual drug development. Our subject matter expertise spans across drug substance, drug product and analytical development. As an organization, we proactively employ Quality by Design (QbD) principles to support all phases of drug development and commercial manufacturing.
Regulatory compliance, including adherence to cGMP requirements, is necessary to ensure safety and efficacy of pharmaceutical supplies. It is also a key component for successful product development, regulatory approval and eventually maintain an uninterrupted supply chain. Syner-G offers consulting to design and implement science and risk-based approaches for quality compliance.