Thanks to a substantial knowledge of the pharmaceutical industry and a strong scientific background, RLM Consulting provides international regulatory affairs support at all stages of product development, from discovery research through preclinical and clinical testing, up to and beyond submission of the dossier for marketing authorization. Our very experienced staff provides strategic guidance (most appropriate regulatory scenario) as well as practical feedback to drive the development of medicinal products. RLM Consulting has a strong experience in writing and negotiating with national agencies and the EMA: briefing documents for scientific advice requests, orphan drug designation dossiers, advanced therapy medicinal status, clinical trial applications (IMPD, IB) and marketing authorisation applications with the Authorities.
Over the past 15 years, RLM Consulting has helped more than 130 small and medium EU and US companies developing innovative medicinal products with different approaches: recombinant DNA proteins, vaccines (live, inactivated, preventive and therapeutic), cell therapy and gene therapy.
RLM Consulting recently launched a new activity: scientific writing e.g. for pricing and reimbursement dossiers.