Principal Consultant

Dr Monica Escobar

Monica has over 20 years experience in the pharmaceutical industry. She has extensive experience in CMC regulatory affairs supporting both investigational and marketed products. Monica is also an assistant professor at the University of Georgia, International Biomedical Regulatory Sciences Program, teaching online Regulatory CMC and GMP courses.

Key areas of expertise
  • Highly skilled at authoring CMC documents for submission in INDs, ANDAs, NDAs, and DMFs
  • Determining CMC regulatory strategy for new drug applications and 505(b)(2) NDAs
  • Developing strategy for post approval changes that require filing with the FDA
  • Regulatory CMC experience in drug-device transdermal and topical patches, oral tablets and capsules, veterinary sterile injectables, veterinary chewables.
  • Highly skilled at leading cross-functional teams to respond to health authority information requests
  • Experienced author for FDA meeting briefing documents and representing the sponsor in FDA interactions
  • Project management of cross-functional project teams
  • Experienced US Agent and DMF Agent
 
Before NDA

Before joining NDA, Monica worked in the pharmaceutical industry, primarily in CMC regulatory strategy for small molecule investigational and marketed products. She has experience with human and veterinary small molecule drugs and with oral formulations, parenteral liquids and drug device combination products, specifically transdermal and topical patches. Monica is also an experienced US agent and DMF agent.

Dr Monica Escobar

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