Clinical & Regulatory Writing
Regulatory medical writing addresses the specific writing needs of sponsor companies to align with increasingly complex global regulatory requirements.
Writing reports for the non-clinical, clinical and post-market documentation of processes, safety and effectiveness of drugs, biologics and devices, the function of a regulatory medical writer is to provide high-quality, accurate scientific documents to satisfy the requirements of the targeted regulatory authority.
Regulatory medical writers must have an understanding of biostatistics, data review, regulatory style requirements, preferred terminology and the clinical research process in order to present highly complex scientific data that accurately reflects the results of the clinical trial.
At Nascent, our regulatory team has demonstrated experience in all types of writing and project management across multiple therapeutic areas.
Nascent Medical provides a single point-of-contact to interface with clients’ own cross-functional team members from data management, science, biostatistics and regulatory affairs to provide value-driven, accurate regulatory writing services to meet the needs of the client.
The participation of the Nascent Medical regulatory medical writing team ensures the entire writing process, from protocol development, submission, and post-market surveillance, is streamlined and effective.
Sponsor companies and CROs are continually challenged to provide the required, high-quality regulatory reports and documents to the appropriate regulatory agencies within tight timelines and often while managing competing priorities.
Whatever your regulatory writing needs, the team of expert writers at Nascent Medical understands these expectations and are ready to deliver your next project.