Medicinal products

Marketing-Authorisation-as-a-Service (MRP, DCP, CP)

Marketing Authorisation on the Fontane Pharma GmbH as MAH as-a-Service

Function of the local representative in Germany

Clinical studies: development and Due Diligence of IBs, Safety Management Plans

Strategic consultancy

Dossier Due Diligence

Compilation of distinct parts of the Marketing Authorisation Dossier (Modules 1/3, Risk Management Plan, clinical overview, eCTD)

Wholesale-dealer-license-as-a-Service

Condution of audits (GDP, GVP, Audits of Drug Safety in  clinical studies)

We take over the position of the responsible person for the wholesale with medicinal products, Information Officer, German local QPPV, external EU-QPPV

Support to establish your own pharmacovigilance system

XEVMPD/IDMP