Medical Writing

Medical Writing that Supports Regulatory Success

High-quality medical writing is important to the regulatory success of our clients. Our medical writing writers have the therapeutic expertise necessary to deliver high-quality written material.

Our medical writing services include:

Development of a study protocol according to ICH GCP and local requirements/optimization of your study design.
Development of patient information and informed consent.
Development of other essential study documents (e.g. Investigator Brochures, amendments, advertisements for subject recruitment).
Certified Translations
Publication and Presentation Material
Presentation of results.

“This application required exquisite organization, teamwork and perseverance. We submitted about 350 pages of highly scrutinized regulatory documentation. Especially considering that we received only a couple minor requests for updates, this was an impressive effort.

Such a high-quality submission, followed by a similarly high-quality pre-clinical, non-clinical and CMC program, along with high-quality QC, organization, summaries and interpretation of dozens of reports; all accomplished just about a year after we nominated the clinical candidate.

Thank you for your contribution to the successful delivery of this historic company milestone.”

– President and CEO

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