Periodic Safety Reports & Medical Writing

We have extensive experience in authoring clinical and postmarketing period safety reports - both "big" and "small" and for a wide range of products. Report formats include:

  • Periodic Safety Update Reports (PSURs)
  • Periodic Benefit-Risk Evaluation Reports (PBRERs)
  • Development Safety Update Reports (DSURs)
  • Periodic Adverse Drug Experience Reports (PADERs)

We can contribute individual sections or produce full, ready-to-submit regulatory documents. In either case, format and content are in line with all applicable regulations and guidelines such as GVP, ICH, US CFR and CIOMS, as well as in compliance with your organisation's procedures and standards.