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MEDIBRIDGE Medical Affairs proposes its expertise for preparing the marketing authorisation applications for all your healthcare products.
Strategic advice
• Evaluation of the product profile compared with that of the competitor products • Evaluation of the medico-legal environment: level of satisfaction with current products, medical needs, special regulations, …
Appraisal
Clinical and toxicopharmacological dossiers
• Evaluation of existing data • Proposal of complementary elements if appropriate • Literature review • Writing of expert reports (EU-CTD format)
Transparency dossiers
Extensions of indication
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