Medical Writing and Regulatory Submissions
With superior skill in medical writing, the PROMETRIKA team works closely with your medical staff to produce documents consistent with your company standards.
We have written numerous clinical trial protocols and integrated clinical/statistical reports; clinical sections of NDAs, including integrated summaries; and other documents for regulatory submissions
(
see Summary of Medical Writing Experience).
PROMETRIKA expertise in documents and regulatory submissions includes:
- Clinical Development Plans
- Clinical Study Protocols
- Clinical Trial Reports – Phase I to Phase IV
- Clinical Sections of NDA (ISS, ISE, and Other Summary Sections)
- Clinical Sections of IND
- Journal Articles, Abstracts, Posters
- Investigator Brochures
- Annual Reports
- Standard Operating Procedures
- Briefing Documents (supporting IND and other FDA submissions)
- Common Technical Documents