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Regulatory Submission

Regulatory Submission

Brightech’s regulatory submission team is composed by experienced medical writers, regulatory experts, statistical/programming team and eSub experts. We have successfully completed over 30 New Drug Application/Biologics License Application NDA/BLA submissions without a single refuse to file(RTF).

Services include

(but not limited to):

  • NDA/BLA submission strategy
  • Project coordination and management
  • ISS/ISE writing
  • Legacy data standardization (SDTM) and standard data package (SDTM/ADaM)
  • P21 compliance checking and fixing
  • SDTM CRF annotation, Define.xml creation and Reviewer’s guide development
  • Entire submission package (eCTD format) preparation and eSubmission