
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
MA
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
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Regulatory affairs Services
+358 20 744 1519 / contactus@medfiles.eu