Regulatory Affairs

Your partner, AGON

Do you need strategy consulting for acquiring marketing authorisations, managing your marketing authorisation procedures (national or international), or in expanding your product range? Do you lack the resources to maintain existing marketing authorisations, such as issuing notifications of variations or conducting formatting updates on the marketing authorisation documentation? If that is the case, we are your perfect partner for any questions on how to maintain your marketing authorisations or use your dossiers in new markets.

Our services

  1. 01

    Project Proposals and Consulting

    for existing marketing authorisations or notifications of variations

  2. 02

    Preparation of Marketing Authorisation Dossiers

    in e-CTD format in English, also based on your existing documentation

  3. 03

    Support for Marketing Authorisation Procedures

    national and international, marketing authorisation strategy consulting

  4. 04

    Updating of Marketing Authorisation Documentation

  5. 05

    Implementation of Variation Procedures

  6. 06

    Preparation of e-CTD Baseline Dossiers

    for existing marketing authorisations

Submit a project request now!

You can rely on our well-established knowledge and expertise. Our team will be happy to advise you.

Contact us