RLM Consulting provides a wide range of regulatory affairs supports for the development of disruptive Investigational Medicinal Products (IMP) and Investigational New Drugs (IND), from early nonclinical development to the late phases of clinical development. We aim to accelerate your journey with the best regulatory pathway in Europe and in the United States of America. Our consultants, all highly skilled in science and regulatory affairs can guide you on the chemistry, manufacturing, control, nonclinical and clinical requirements. We act as an applicant for various submissions to the European national agencies, to the European Medicines Agency (EMA), as well as to the US Food and Drug Administration (FDA). We do not only submit your files: we also write the content of your dossier, including briefing books for consultations with agencies, Investigational Medicinal Product Dossier (IMPD), modules of IND, Investigator’s Brochure (IB), Orphan Drug Designation (ODD), Paediatric Investigation Plan (PIP)/Paediatric Study Plan (PSP), PRIME designation request, Breakthrough Therapy designation request,…Our key expertise covers several medicinal products, including mRNA products, small molecules, peptides, monoclonal antibodies, fusion proteins, vaccines, cell therapies, gene therapies, Live Biotherapeutic Products (LBP) and Genetic Modified Organisms (GMO).
