Regulatory affairs / Marketing authorisation

Preparing, submitting and maintaining CTD / eCTD documentations, for example, places considerable demands on a company's human resources. Diapharm relieves you of this burden.

Medicinal products

We take over and manage all phases of the marketing authorisation procedure for you:

• Centralised procedure (CP) at the EMA
• Decentralised procedure (DCP) in all EU member states
• Mutual recognition procedure (MRP) in all EU member states
• National procedures at all EU drug regulatory agencies (Afssaps, BfArM, DKMA, MHRA, MEB, etc.)
• Regulatory procedures for veterinary medicinal products (e.g. at the BVL)
• Traditional herbal registrations (THR), traditional herbal medicinal products (THMP)
• Preparation of registration files as CTD / eCTD
• Handling of deficiency letters
• Marketing authorisation renewals

Food supplements, medical devices, cosmetics

In addition to marketing authorisations for medicinal products Diapharm manages regulatory tasks for other product categories such as notification, reporting and regulatory procedures, among others:

• Notification procedures for dietary foods
• Compliance assessment procedures for medical devices
• Reporting procedures, e.g. to BfR (cosmetics) or DIMDI (medicinal products)
• Certification procedures, e.g. CE mark for medical devices
• Regulatory procedures, e.g. for health claims for food supplements
• Communication with regulatory authorities

Our experts for regulatory affairs will guide you safely through the numerous and varied national and international procedures. From registration to DCP or MRP approvals procedures – we provide comprehensive support.

For more information visit www.diapharm.com