Medical and Regulatory Writing

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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 FDA and EMA
Regulatory Review – consistency of message, regulatory commitments
Clinical Documents – support for labeling
Document QC – data integrity

Examples of Regulatory Document Services:

IND, NDA and MAA Modules (2.4, 2.5, 2.6, 2.7)
Investigator’s Brochures
Pre-INDs
DSURs
Regulatory Responses
Pediatric Plans
ISS/ISEs
Briefing Books
Lay Summaries (EU)
Health Authority Meeting Materials

Examples of 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 mid-size pharmaceutical, biopharmaceutical, and medical device companies, advancing the development and registration of their products worldwide. Today, we are a highly-qualified and passionate team of experts with deep experience in health authority interactions and in the preparation of complex regulatory submissions requiring specific and strategic regulatory expertise.

Medical and Regulatory Writing

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Medical and Regulatory Writing

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North Carolina

San Diego

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