Head office
Newton Street

+44 (0)1625 412500

Regulatory writing

Our highly-experienced regulatory writers integrate seamlessly with your team to ensure your clinical documentation is delivered to the highest standards.

We have the skill and expertise to interpret and summarise complex data, producing high-quality, concise, content that complies with regulatory guidance.

Our personal approach is unique. We take pride in surpassing our client’s expectations by listening carefully, understanding the challenges, and providing expert and flexible solutions.


We can support all of your clinical regulatory documentation needs, including:

  • IND/CTA packages
  • Investigator's brochures, protocols, CSRs, narratives
  • Briefing books
  • CTD submission modules
  • Regulatory responses

What impressed me most was the ownership that you took of the clinical documents. We trust our suppliers implicitly to lead the submission process, and you have more than fulfilled that trust. Thank you again and congratulations!

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