Magenta Pharma Consulting BV
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Magenta Pharma Consulting BV offers regulatory intelligence in the development of a drug product.
We provide tailor made guidance and support to pharmaceutical companies during all stages of the registration process of a medicinal product ranging from pre-authorisation strategic advice, dossier development and writing,  marketing authorisation application up to post-marketing life-cycle management.

Regulatory Affairs
Magenta Pharma Consulting has successfully been involved in many regulatory marketing authorisation procedures of medicinal products. The company combines regulatory intelligence with hands-on support during Regulatory procedures (CP, MRP/DCP, NP) related to:
  • Marketing Authorisation Applications (MAA, submissions and follow-up)
  • Marketing Authorisation Maintenance
  • Product Dossier (development, writing, compiling, submitting and follow-up)
  • Preparation and updating of Product Information texts (SmPCs, Patient Leaflets, Labelling)
  • Due Diligence of Marketing Authorisations
Magenta Pharma Consulting is familiar with documentation requirements for the regulatory procedures (e.g. quality technical files (module 3), eCTD), non-clinical, clinical and pharmaceutical overviews).

Miscellaneous Services
In addition to our Regulatory Affairs services, we gained experience in other related disciplines as well.
Please contact us for more information.


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