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Regulatory Medical Writing

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Our Regulatory Medical Writing Department has been established for more than 25 years. It consists of approximately 100 staff, comprising medical writers, editors, quality control (QC) auditors and publishers, all of whom are located in the U.S. and Europe. We have the in-depth experience required to develop high quality documents quickly, and also the flexibility to adapt and meet your needs, no matter the size of your writing project.

We consist of 4 divisions: Preclinical, Early Clinical (Phases I-IIa), Late Phase (Phases IIb-IV) and Document Services (QC, Editing and Publishing).

Clinical Regulatory Documents

Our team of PhD and master’s level writers with diverse therapeutic backgrounds can support preparation of a wide range of clinical regulatory documents, including:

  • Clinical Protocols, Clinical Study Reports (CSRs), patient narratives
  • Investigator Brochures
  • CTD summaries
  • Integrated analyses of effectiveness and safety (ISE / ISS)
  • INDs, IMPDs and annual reports
  • Product circulars, summary of product characteristics (SmPCs)
  • Agency background packages
  • Pharmacovigilance documents
  • Manuscripts, abstracts, posters and presentations
  • Literature reviews
  • Quality control checks before document submission
We can also provide stand-alone quality control and editorial reviews for documents that you have either developed in-house or received from a freelance writer.

Your Product Deserves Exemplary Publishing

Whether you need deliverables in traditional or electronic Common Technical Document (eCTD) format, our publishing team is prepared. And because we know you need to consider regulatory compliance, our industry-leading tools for document management and electronic publishing meet all standards for United States Food and Drug Administration (US FDA) guidelines and International Conference on Harmonization (ICH) guidelines.

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