Syner-G Pharma CMC Consulting | Providing full spectrum of customized CMC Regulatory services for Bio-Pharmaceutical companies
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Consulting with a
> Passion for Science
> Dedication to Client's Success
> Commitment to help Patients

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Proven Strategic Solutions
for all Your CMC Challenges!

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Customized, Science and Risk-based approaches for full spectrum of CMC needs

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.

Three Core Business Areas

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.

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.

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.

EXPERIENCE – Our Difference

  • Innovative Science-Based Regulatory Strategies
  • Customized Solutions to Resolve Your Project Issues
  • Responsive and Timely Solutions
  • Our Broad Experience
  • Good Value on Your Return on Investment

HOW CAN WE HELP YOU?

Contact Us