Mazerolles Consultants proposes

  • Technical assistance:

    • Writing (in English or French, in accordance with the current French and European regulation)

      • MA dossier preparation in CTD format (Modules 1 to 5 and submission of the dossier to the Authorities), particularly for the generic medicinal products.

      • Evaluation and presentation of MA dossier in CTD format.

      • Veterinary Marketing Authorisation dossiers.

      • Other scientific reports (variation dossiers, IMPD, notifications, answers to the questions of the Human and Vet Agencies).

    • Scientific documentation :

      • Bibliographical syntheses

      • Information on drug documentation

  • Translation of scientific documents (French/English and English/French)

  • up-to-date information reports on technical and regulatory issues

  • Subscription technical and regulatory consulting

Clotilde Mazerolles is a Doctor in Pharmacy since 2001. After she worked as scientific assistant then regulatory affairs responsible in a veterinary pharmaceutical laboratory, she worked as head of regulatory affairs in a CRO working under contract for pharmaceutical industry mainly within the framework of generic drugs development.
Since 2007, she works as freelance regulatory consultant near companies providing pharmaceutical industry or as a regulatory consultant under contract for international pharmaceutical laboratories.

We propose the preparation and presentation so much in English than in French of human and veterinary Marketing Authorisation documents, the reformating of Marketing Authorisation dossiers (CTD format), the preparation of variation dossiers and answers to the questions of the human and veterinary Drug Agencies.

Engagement of quality :

  • Respect of the deadlines : we commit ourselves respecting the time allowed with the customer for the service requested.

  • Relations with the customer : we commit ourselves to hold informed the customer of the progress report of its project and answering its requests within the shortest times.

  • Estimate - invoicing : we establish an estimated cost for each request and we establish an invoice after finalization of the service and reception of work by the customer.