Sarah Hlavachek, B.S.

Director, Regulatory Affairs

Sarah holds a BS in Chemistry from University of Wisconsin, Madison. She began her career in pharmaceutical development as an analytical chemist at PPD Development and Sepracor and then moved to CMC regulatory affairs. Sarah has over 16 years of experience in CMC regulatory affairs for small molecules, biotechnology products and drug device combination products. She has managed several regulatory submissions at various companies across all stages of development, from pre-submission consultation meetings (pre-IND), Phase 1 through 3 clinical trial applications, to marketing applications and post-approval supplements. Her global CMC experience includes submissions in the US, Europe, Japan and Canada for investigational and marketed products.

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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