Our Services

Proven Strategic Solutions for all your CMC Challenges

CMC Regulatory Affairs

The CMC regulatory landscape is continuously evolving and presents a steady challenge to the development of new drugs and biologics.  At Syner-G, we understand this landscape. We are experienced and passionate in helping our clients to design, plan and execute CMC strategies critical for the successful development and timely approval of new drugs.

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CMC/Pharmaceutical Development

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.

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Quality/cGMP Compliance

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.

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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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