Regulatory Writing and Submissions


SRC has experience in the preparation of many types of regulatory submissions, for drug as well as medical devices. SRC can assist with the preparation and filing of the traditional regulatory submissions for both drugs (INDs, Annual Reports, FDA meeting requests and briefing documents) and medical devices (510(k)s, IDEs). SRC can also assist with more specific types of regulatory submissions, including:

  • Orphan drug disease designation
  • Rare Pediatric Disease Designation
  • Fast Track and Breakthrough Therapy Designation

In addition to these regulatory submissions, SRC has extensive experience in offering companies formal training courses in Medical and Technical Writing. Zeinab Schwen, MS has been providing professional training in the areas of both medical and technical writing, for over 20 years. She is past president of the Ohio Regional Chapter of the American Medical Writers Association.