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