REGULATORY AFFAIRS

At Medicorent, most of the staff are permanently employed consultants who are carefully selected and recruited by us to fit into the role of consultancy and thereby being able to adapt to various assignments. In addition, we also work with subcontractors to be able to offer a whole range of skills and experience to match the desired profile for the client. The Regulatory team also possesses competencies from other positions such as PV and QA, which are skills valuable whether being devoted entirely within Regulatory or in combined roles.

The Regulatory interim team provide competency solutions mainly full-time and based at client locations. The client scope stretches from small-, to medium- to big global pharma companies and the assignments can vary from national to global responsibilities. We cover competencies within pharmaceuticals, biologics, vaccines, medical device, cosmetics, generics, parallel import, and distribution.

We tailor the solutions to your needs and our consultants can support you with:

• Drug development and CMC

• Regulatory Strategies

• New Drug application (NDA) for US and Marketing Authorisation Approval (MAA) for EU

• Initial Clinical Trial Application (CTA) and Substantial Amendment (SA)

• Authority interactions and negotiations within and outside the EU

• Geographic expansion and launches

• Life Cycle Management
  - Product responsibility and maintenance; submissions and annotations, product information, translations, variations, artwork (reviewal and creation), labelling

• MAH transfers

• Regulatory Compliance