MDC RegAffairs GmbH is …
… a consultancy company offering services in the field of drug regulatory affairs and drug development.
MDC RegAffairs combines broad regulatory expertise with an efficient and dedicated team to manage EU and US regulatory procedures. Our expertise comprises small molecules, protein drugs as well as advance therapy medicinal products (ATMP) for the treatment of a wide variety of diseases including for example cancer, autoimmune disorders, ophthalmological conditions as well as dermatological, metabolic and infectious diseases.
Along with our flexibility and responsiveness, our clients can count on our expert advice and counsel to get tailor-made regulatory strategies.
Our focus is on
- Orphan drugs,
- Paediatric regulation (Paediatric Investigation Plans/Waiver),
- European authorisation procedures,
- Regulatory and drug development strategy.
Our clients can be confident that they are receiving the highest quality and most diverse regulatory consulting services from MDC RegAffairs.