The writing of regulatory reports and summaries that both conveys the applicant’s message and are in line with applicable regulations and guidelines is a skill of it’s own. Our medical writers are specialised in the regulatory documents for your applications.
During drug development…
…we support you with the writing of complex summaries and expert reports such as briefing documents for scientific advice, or documents for clinical trial / investigational new drug applications (CTR / IND) such as Investigator’s Brochure (IB), investigational medicinal product dossier (IMPD). All in consultation with scientific / therapeutic area experts.
In time for a marketing authorisation application, all areas from product information via risk management plans, overviews, quality data and study reports needs to be documented in accordance with current legislation and guidelines. Our team covers what you need.
The eCTD dossier is to be compiled and published by the book with a dedicated software. Let us do that for you.