top of page

Scientific Writing

Drug development is a complex process that involves rigorous scientific and regulatory writing. For the best understanding and accurate communication of the underlying science, experienced and high-quality writers are of utmost importance.

At ClaritiDox, we have over 20 years of writing experience and can support and advise you with all types of documents from preclinical to post-marketing phase.

Our writing team is represented globally and has:

Senior and above level writers with excellent communication skills, including PhD-level scientists and physicians.

A wide range of therapeutic area expertise, including rare disease and gene therapy.

Robust understanding across multiple areas of drug development (regulatory affairs, CMC, clinical, nonclinical).

Wide expertise on document strategy.

Extensive experience in writing documents throughout all phases of drug development.

Significant team and project management expertise with the flexibility to easily integrate your company culture.

Flexible processes, enabling your company to customize at the program, product, or even document level​.

The ability to scale the support according to your needs.

The resources to provide 24-hour writing support to your projects.

Documents we write include the following:

Submissions

  • Clinical Summaries and Overviews for INDs, BLA/NDA/MAAs

  • Integrated Summaries of Efficacy and Safety

Strategic Regulatory Documents

  • Orphan Drug Designation

  • Pediatric Plans

  • ​Fast Track Applications

Nonclinical

  • Nonclinical Study Reports

  • ​Nonclinical Written and Tabulated Summaries

Health Authority Interactions

  • Briefing Books

  • ​Regulatory Responses

Study-Level Documents

  • Protocols

  • Clinical Study Reports

  • Investigator Brochures

  • ​​Patient Narratives

Medical communications

  • ​Manuscripts

Services we provide

Submission Leadership

At ClaritiDox, we are experienced project and team managers and are fully equipped to support you from small to large scale projects.

Strategic Regulatory Writing

At ClaritiDox, our writers have exceptional knowledge in multiple therapeutic areas and have led multiple submissions, including some of the first gene therapies on the market. We love to use our experience in meaningful ways. We are uniquely suited to support you with your most challenging projects.

Writing Support

Our global team of highly experienced writers is available to provide round-the-clock 24-hour writing support to all document types. Any writing task you need, we are available to support you.

What our clients say

"ClaritiDox is our go-to vendor for our high-profile projects because we trust them to deliver documents that meet our quality standards the first time around. Our timelines are often accelerated, and our study teams have competing priorities; yet, ClaritiDox consistently collaborates with us to meet our goals. They are the one vendor we just don’t worry about.”

Director of Regulatory Affairs

- Small Biotech

bottom of page