Services
At MDC RegAffairs we are particularly focused on the development and authorisation of drugs for children and orphan drugs as well as European authorisation procedures.
Our services comprise preparation of regulatory documents, management of regulatory procedures at national agencies and the European Medicines Agencies (EMA), and organisation of agency meetings. In addition, we offer In-House seminars on regulatory topics and project management in R&D.
Our core expertise is:
Orphan Drugs
- Orphan designation in the European Union and the US
- Annual reports
- Transfer of Orphan Designation
- Authorisation of orphan medicinal products
Paediatric regulation
- Definition of the development strategy for the paediatric population
- Paediatric Investigation Plan (PIP) application/request for waiver
- Request for modification of an agreed PIP
- Compliance Check
European Authorisation Procedures
- Development of authorisation strategy
- Compilation of eCTD
- Management of marketing authorisation procedure (Centralised procedure, Mutual recognition and decentralised procedure)
Drug development
- Project management
- Regulatory and development strategy
- Organisation and management of scientific advice meetings
- Preparation of regulatory documents (e.g. IB, IMPD)
In-House Training
- Project management in Pharma R&D
- Orphan drugs
- Paediatric regulation