Periodic and Annual Reports 

B&H helps to assure that our clients are compliant with various regulations such as US 21 CFR 312.23 and 21 CFR 314.80 and 314.81, EU Clinical Trial Safety Reports, Annual Reports on the state of development of designated orphan medicinal products, and pharmacoviligence Periodic Safety Update Reports.

• To prepare periodic and annual reports for submission to Regulatory Authorities. B&H tasks include:
  • Issuance of the “Call for Information”
  • Collection, review and verification of source data for accuracy
  • Preparation/circulation of draft report
  • Revisions to the report, as necessary
  • Preparation of the appropriate form and cover letter
  • Issuance of the final annual report
  • US obligations, issue FDA form and cover letter for final review and signature
  • Duplication, QC of copies, and submission to Heath Authorities and/or internal client distribution  

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