Amy Clark-Stasiw

Manager, Regulatory Submissions and Documentation

Amy has over 20 years of experience in the pharmaceutical industry. She started out as a microbiologist/bench chemist and worked her way through the different facets of the business including quality, analytical, stability and lastly regulatory. Ms. Clark-Stasiw has authored IND, IMPD, NDA, ANDA, CBE and PAS submissions, as well as, Annual Reports for regulatory agencies in the US, Canada and Europe. Ms. Clark-Stasiw is also very experienced in preparing submissions for electronic publication (gateway ready documents) and understands the publishing needs of regulatory operations teams.

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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