Marketing authorisation applications

Medfiles’ highly educated expert team has an average of over 12 years of experience in regulatory work, both in the pharmaceutical industry and from an authority perspective, with each member of our team having at least one week per year additional training, ensuring that we are always up to date on the latest requirements. We can take care of the complete marketing authorisation application process from registration strategy to marketing authorisation, including a project manager and a dedicated team, or you can outsource us parts of your process if you need an extra pair of hands. From product classification and scientific advice through application process – we assist you en route to bringing your product from research phase to market. We can provide you with comprehensive training regarding new marketing authorisation applications and strategical issues.

Regulatory strategy

Correct strategic decisions
Product classifications
Scientific advice

Evaluation of MA dossiers

Due diligence
Gap analysis

Preparation and management of applications

Appropriate documentation in compliance with the requirements
Possibility to act as applicant and MAH

Coordination of MRP, DCP, NP, CP and AIR

Efficient management of the regulatory process
eSubmission intelligence


Smooth process from product development to market launch

Our services include:

  • Planning of marketing authorisation strategy
  • Preparation and management of applications
  • Evaluation of marketing authorisation dossiers
  • Coordination of MRP, DCP, NP and CP processes
  • Acting as applicant and Marketing Authorisation Holder
  • Project management
  • Consultation regarding e.g. product classifications, scientific advice and national requirement
  • Training

For more information please contact

Let’s chat