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
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Clinical Summaries and Overviews for INDs, BLA/NDA/MAAs
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Integrated Summaries of Efficacy and Safety
Strategic Regulatory Documents
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Orphan Drug Designation
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Pediatric Plans
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​Fast Track Applications
Nonclinical
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Nonclinical Study Reports
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​Nonclinical Written and Tabulated Summaries
Health Authority Interactions
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Briefing Books
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​Regulatory Responses
Study-Level Documents
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Protocols
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Clinical Study Reports
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Investigator Brochures
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​​Patient Narratives
Medical communications
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​Manuscripts
Services we provide
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.
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