Medical and Regulatory Writing

RPI provides technical and medical writing and editing services for regulatory submissions in eCTD format. RPI’s document preparation services include:

Regulatory/health authority submission documents for the FDA and EMA
Regulatory review – consistency of message, regulatory commitments
Clinical documents – support for labeling
Document quality control – data integrity

Regulatory Document Services

Investigational new drug, new drug application, and market authorization application modules (2.4, 2.5, 2.6, 2.7)
Investigator brochures
Pre-INDs
Development safety update reports
Regulatory responses
Pediatric plans
Integrated summaries of safety and integrated summaries of effectiveness
Briefing books
Lay summaries for the European Union
Health authority meeting materials

Clinical Document Services

Protocols
Protocol amendments
Clinical study reports
Annual reports
Narratives
Executive summaries

After having worked with RPI for many years now, my expectations were naturally high. Once again, RPI’s outstanding staff delivered, on time, a clean submission. I deeply appreciate RPI’s depth of experience in terms of both regulatory strategy and publishing operations.

Jamie Cope

VP – Translational Medicine, Reset Therapeutics

RPI was founded in 1995 to serve the growing needs of small to midsize pharmaceutical, biopharmaceutical, and medical device companies, advancing the development and registration of their products worldwide. Our highly qualified and passionate experts have deep experience in health authority interactions and in preparing complex regulatory submissions requiring specific and strategic regulatory expertise.

Medical and Regulatory Writing

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