Accelerating Your Regulatory Journey
RLM Consulting provides regulatory affairs support at all stages of the medicinal product development, from discovery research through preclinical and clinical testing, up to and beyond submission of the dossier required for marketing authorization.
Our experienced staff provide strategic guidance to achieve the most appropriate regulatory scenario as well as practical feedback to drive the development of medicinal products.
Negotiating with authorities
We have extensive experience in writing and negotiating with national agencies, EMA and FDA, and providing briefing documents for scientific advice requests, orphan drug designation dossiers, advanced therapy medicinal status, clinical trial applications (IMPD, IB) and marketing authorization applications with the Authorities.
RLM provides regulatory support at all stages of the medicinal product development.