World’s Leading CMC Consultants

We provide customized science and risk-based approaches for a full spectrum of CMC needs.

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Our Vision

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.

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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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Become a Valuable Member of the Syner-G Team

These positions and more can be found on our Careers page as well.

CMC Regulatory Affairs Consultant
Job Category: Consultant
Job Type: Full Time
Associate Director/Director Formulation Development
Job Category: Director
Job Type: Full Time
QA Document Control Specialist
Job Category: Project Manager
Job Type: Full Time

Careers @ Syner-G

Syner-G is growing and we are always looking for experienced Regulatory CMC professionals to join our team.

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FDA News & Updates

The latest news, updates, and press announcements from the U.S. Food and Drug Administration (FDA) so that you can stay in the loop!

FDA FAST FACTS
PRESS ANNOUNCEMENTS

Global Health Authorities

We regularly work with major health authorities to ensure that your life saving products will reach the people who need them.

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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