About Syner-G

Why Choose Syner-G?

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.

What Sets Us Apart

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

Meet the Team

Prabu Nambiar, Ph.D. MBA, RAC
Principal and Founder

Prabu acquired his Ph.D. in Organic Chemistry from Oregon State, completed his post-doctoral training at Brown University and got his Executive MBA from Boston University.  He has over 25 years of industry experience including last 20 years in CMC Regulatory Sciences.  His extensive CMC experience includes resolution of complex CMC/Quality and Compliance issues (regulatory starting materials, Genotox impurities, specifications, QbD implementation, PAI responses) using science and risk-based approaches and leading NDA/Regulatory Teams.  He has worked in various therapeutic areas and on a broad range of dosage forms including immediate and modified release oral products, inhalation products, sterile injectables and drug-device combination products.  He has led the filing and approval of 11 NDAs, numerous sNDAs, INDs and international filings.  He is a member of RAPS, ACS and AAPS and was the chair of Regulatory Science section at AAPS.

Binesh Prabhakar, MBA

Partner
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Drew Barlow, M.P.H.

Vice President, Head of Regulatory Affairs
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Edward Ciolkowski, Ph.D.

Vice President, Head of Technical Development and Outsourcing Management
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Ray Forslund, Ph.D.

Vice President, Head of CMC Development and Project Management
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Marsha Marande, Ph.D.

Vice President, Regulatory Affairs
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Jay Samudralwar, Ph.D.

Director, Regulatory Affairs
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William O’Brien, Esq

General Counsel and Vice President, Operations
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Sarah Hlavachek, B.S.

Director, Regulatory Affairs
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Velvizhi Heine, Ph.D., RAC

Director, Regulatory Affairs
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Anuj Kumar, Ph.D.

Director, Pharmaceutical Development/CMC Project Management
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Milind Dixit, Ph.D.

Director, CMC Formulation Development and Operation
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Lyndon Marble, Ph.D.

Associate Director, CMC Development and Project Management
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Venkata Ratnala, Ph.D.

Senior Manager, Regulatory Affairs
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Amy Clark-Stasiw

Manager, Regulatory Submissions and Documentation
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Wayne Schairer, M.S.

MS – Manager, CMC Development and Project Management
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Rajan Thumar, M.S.

Consultant II, Regulatory Affairs
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Sree Hemanth Tummala, M.S.

Consultant I, Regulatory Affairs
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Geetha Tula, M.S.

Consultant I, Regulatory Affairs
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Anu Peter, M.S.

Consultant I, Regulatory Affairs
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Sanjana Reddy, M.S.

Consultant I, Regulatory Affairs
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Avani Shah, M.S.

Jr. Consultant, Regulatory Affairs
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Advisors

Dr. Neal Anderson 
President, Anderson’s Process Solutions
Ex-BMS
API Process and Manufacturing

Dr. Gary Maier
MaierMetrics Consulting
Ex-Sanofi/Sepracor/Sunovion
Biopharmaceutics

Dr. Steven Koepke
SRK Consulting, LLC
Ex-FDA Deputy Director

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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