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Service: New marketing authorisations (human medicines)

  • Outsourcing local regulatory affairs: 4 examples of tailored support in the Nordics and Baltics

    08.10.2026

    Outsourcing local regulatory affairs: 4 examples of tailored support in the Nordics and Baltics
  • Selected non-prescription medicines to be sold outside pharmacies in Finland

    08.09.2026

    Selected non-prescription medicines to be sold outside pharmacies in Finland
  • Cooperating with Baltic medicines authorities in regulatory submissions: Practical experiences from Estonia, Latvia and Lithuania

    25.08.2026

    Cooperating with Baltic medicines authorities in regulatory submissions: Practical experiences from Estonia, Latvia and Lithuania
  • Flexible regulatory outsourcing: choosing the level of support that fits your needs

    22.07.2026

    Flexible regulatory outsourcing: choosing the level of support that fits your needs
  • How to obtain a marketing authorisation in the EU – requirements and approval process for medicinal products

    26.06.2026

  • Q&A: What makes a strong Module 3 quality dossier

    27.05.2026

    module 3 dossier
  • Entering the EU pharmaceutical market: Q&A on new marketing authorisations

    27.05.2026

    Entering the EU pharmaceutical market
  • Embedded expert support for RA & PV teams: a flexible alternative to hiring and full outsourcing

    13.05.2026

    Embedded expert support
  • How to implement common Baltic packs for human medicines

    28.04.2026

    How to implement common Baltic packs for human medicines
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