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You
want to register medicinal products or drug substances, Médipha
Santé mainly occurs at:
Marketing
authorisation application
- Dossier
evaluation
- CTD format registration
- Regulatory submission
- Update of the dossiers (variations, responses with the authorities…)
- Writing of administrative parts as SPC, package leaflet…
- Translation of product information
- Post-approval license maintenance
Drug
substance
- Dossier
evaluation
- Submission to EDQM (CEP)
- Follow up of the application
Follow
up of the Marketing Authorisation
Médipha Santé can follow up and realizes the maintenance
of your MA. For you, we realize :
- Renewals
- Variations
- Price and reimbursement application
- Pharmacovigilance (PSUR submission via Eudravigilance)
At
each step, we evaluate your dossier and we assist you for the writing,
the submission and the follow up with the authorities.
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