Compliance with GDPR Respecting your privacy

Consulting Regulatory affairs input and Guidance on

Regulatory Strategy To define a coherent regulatory strategy is not just a matter !

Biotech Products Recombinant DNA proteins - Vaccines - CELL THERAPY

Interactions with Regulatory Bodies RLM Consulting has direct contacts with most EU national agencies and the EMA

Submissions Clinical Trial Applications (CTA) - Marketing Authorisation Applications (MAA)

Due Diligence For the assessment of an investment project - For a client considering licensing in a novel product

Good Research and Laboratory Practice Small and Medium size Enterprises (SME) - Private and Academic Laboratories

Training RLM Consulting provides client specific courses on most aspects of EU

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.

Ideally regulatory guidance should be provided at the earliest possible stage of the product development, but we can help at any stage.

RLM Consulting provides strategic guidance (most appropriate regulatory scenario) as well as practical feedback. When appropriate we seek the advice of regulatory authorities (EMEA and national agencies).