Marsha Marande, Ph.D.

Vice President, Regulatory Affairs

Marsha received her Ph.D. in inorganic chemistry from the University of New York at Binghamton and her BA in Chemistry from Hamilton College. She is an experienced pharmaceutical professional with extensive experience in global CMC regulatory affairs (26 years) for both biotechnology and small molecule products in all phases of clinical development and post-approval. She has extensive experience in process validation, QbD, comparability assessments and protocols, authoring global submissions and responses to Agency queries. She is experienced in defining CMC strategy for early development and late-stage/commercial development of both for biologics and small molecules. She is an accomplished regulatory leader/manager in both early development projects (resulting in successful CTA and IND submissions) and full development programs overseeing the preparation of and successful submission of marketing applications (4 NDAs, 5 MAAs, 3 BLAs). Demonstrated leadership in leading and managing Teams (comprised of internal members as well as partners and vendors) through complex global submissions, difficult supply issues, formal meetings and interactions with numerous global health authorities (including FDA,

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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