Regulatory Affairs

Regulatory affairs connects your company with the authorities: applications and variations, product information and product data, deadlines and conditions. In pharmacovigilance, this mainly concerns everything that safety findings mean for the marketing authorisation.

Marketing authorisation and pharmacovigilance are interlinked: updating the product information after a signal is a variation. A transfer of marketing authorisation also shifts pharmacovigilance obligations. Anyone who looks at the two separately creates gaps precisely at the transitions — and these are the first to show up in acquisitions and restructurings.

Start-ups in the pharmaceutical sector dealing with authorities for the first time. Companies involved in acquisitions, licensing agreements and portfolio takeovers. And marketing authorisation holders that do not want to staff their regulatory tasks permanently in-house.

• Regulation (EC) No 1234/2008 — variations to marketing authorisations
• Article 57 of Regulation (EC) No 726/2004 — electronic submission of product data
• GVP Module XV — safety communication and updating of the product information
• National requirements under the AMG (German Medicines Act), including the appointed responsible persons

• Regulatory consulting and support for start-ups in the pharmaceutical sector
• Contact with authorities and applications
• Pharmacovigilance due diligence in transactions, licensing agreements and portfolio acquisitions
• Support with transfers of marketing authorisation, including the handover of pharmacovigilance obligations
• Referral to specialised partners for tasks outside our core area
• Interim staffing of regulatory functions to bridge vacancies

We see marketing authorisation and drug safety as one chain. Through a network of selected partners nationally and internationally, we can also cover what lies outside our core area — and you still keep one contact person.