Woodbury Biologics Consulting LLC assists in writing CMC dossiers for regulatory submissions.
29 years of experience in Analytical Sciences/Quality Control and Reg-CMC that spans biopharmaceuticals (biosimilars, antibodies, antibody drug conjugates), pharmaceuticals, radiopharmaceuticals (imaging agents and therapeutics), fusion proteins, lentiviral and recombinant adeno-associated virus (rAAV) vectors based cell/gene therapy products.
Successful track record of building new strategies for improving analytical systems, formulations, process development & validation, GMP quality systems and regulatory filing strategies for early and advanced stage biologicals as well as product expansion efforts
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Woodbury Biologics Consulting LLC
82 Southfield Falls
Monroe, NY, 10950
United States
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Woodbury Biologics Consulting LLC
82 Southfield Falls
Monroe, NY, 10950
United States
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