Enabling you to identify and mitigate the intrinsic risk in your operations, supply chains and business processes.
Evaluating how your products and services meet and exceed quality, safety, sustainability and performance standards.
Validating the specifications, value and safety of your raw materials, products and assets.
Bettina Donato, Scientific & Regulatory Consultant, Pharmaceutical & Healthcare Group
Ms. Bettina Donato is a Scientific & Regulatory Consultant with the Pharmaceutical & Healthcare Group of Intertek Regulatory & Scientific Consultancy. In this role, Ms. Donato works closely with clients and scientific and regulatory experts to design and implement nonclinical toxicology programs, monitor nonclinical toxicology studies, and prepare regulatory submissions for pharmaceuticals, biologics, medical devices, veterinary drugs, and other products.
Prior to joining Intertek Regulatory & Scientific Consultancy, Ms. Donato amassed more than 15 years of experience in drug development including 3 years in biotech, where she coordinated the outsourcing needs of Safety Assessment. Ms. Donato previously held positions at a major contract research organization (CRO) in Vienna, Virginia including six years as a Study Toxicologist within the Study Direction group and two years as a technician. She has knowledge of small and large molecule development and a sound understanding of U.S. and International regulations required for research and development success.
With a wealth of nonclinical monitoring experience, Ms. Donato is an advocate for her clients and a facilitator of scientific discussion, development, and ingenuity. She is experienced in the Six Sigma process improvement method and understands the need for efficiency and accuracy within the pharmaceutical and healthcare industry.
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