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Regulatory Affairs

  • Regulatory strategy
  • Regulatory interactions
  • All regulatory submissions to FDA and EMEA (INDs, CTAs, NDA/BLAs, 510(k), etc.)
  • Recall advice and assistance
  • FDA meeting preparation, including advisory committee preparation and MOCK AC boards

 

Epstein Associates will arrange a mock FDA panel meeting.

Our services include the development of a comprehensive panel strategy for the sponsor including organizing a slide presentation, streamlining Q & A and creating a Post Panel Action Report.

Key Services

  • Clinical & Medical Consulting
  • Business Development
  • Pharmaceutical
  • Regulatory Affairs
  • Legal Consulting

News & Announcements

Achieving successful bowel preparation with evening/morning split-dosing regimens of NER1006 versus trisulfate: post hoc analysis of a Phase 3 trial
Jul 25, 2017
Novel 1L Polyethylene Glycol (PEG)-Based Bowel Preparation NER1006 Achieves High Quality Bowel Cleansing with a Lower Volume than Standard 2L PEG + Ascorbate and Under 3L Total Fluid Volume Intake
Jul 25, 2017
Bowel preparation quality of NER1006 versus oral trisulfate solution as assessed by colonoscopists at site: a post hoc analysis from a randomized controlled trial
Jul 25, 2017

410-224-4887 x453

Epstein Associates, LLC
621 Ridgely Avenue, Suite 204
Annapolis, MD 21401

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