Regulatory Writing

Our specialist skills mean we are uniquely placed to understand and manage your pressures and priorities. And no one does that better than our very own in-house regulatory writing team.

We don’t do one size fits all

Our regulatory writing team have experience working in both big pharma and medical writing agencies, including subcontracting and CROs. This breadth of scale means we can adapt to every type of client requirement.

We’re academic aces

Our regulatory writing team all have academic degrees and most have PhDs in a range of disciplines. These include molecular biology, biochemistry, psychology, physiology, pharmacology, pharmacy, nutrition, and research management!

We’re diligent on documents

Need a formal document written fast? Look no further than our regulatory writing team. We have experience writing all kinds of documents including IMPDs, CSPs and amendments, ICFs/IAFs, DSURs, IBs, CSRs, CTD non-clinical and clinical summary documents, RMPs, PIPs/sPSPs, and briefing documents.

The Alchemy team were extremely professional, efficient, knowledgeable, and dedicated, delivering several high-quality regulatory documents and protocols in a timely manner. Their medical knowledge, experience and attentiveness to our needs were evident in the recommendations and prioritization of data. The comments they had for us during the process, ability to anticipate our needs, and responsiveness, irrespective of the time zone difference, is illustrative of a truly personalized experience.

Robert T Keenan, Chief Medical Officer – Arthrosi Angle Design