Strategies and Services for Medicinal Products

We would be pleased to accompany your medicinal products from the product idea through the approval process to quality and lifecycle management including all analytical tasks. Experienced and practice-oriented, in an advisory and executive capacity.

From wholesale distribution authorisation to GMP/GDP audits:

We cover the requirements for your medicinal product on its way to market: in addition to advising on the efficient design of circumstances and processes, we also prepare all the relevant documents in the format required by the authorities to obtain a wholesale distribution licence – including for the differing regulations that apply to special categories of medicinal products such as homeopathic remedies and veterinary medicinal products. On request, we can also act as your external Responsible Person for Wholesale Distribution.

Our experienced auditors assess the GMP and GDP compliance of your manufacturing and distribution processes and support you in preparing for regulatory inspections.

• Regulatory Affairs Services / Registrations
• Development and maintenance of QM systems (GMP, GDP)
• Pharmacovigilance
• Clinical & medical assessment
• Drug / batch release as a service
• Audits (incl. API) & inspections
• Quality control & stability testing
• Release test and EU retest

We take over responsible roles:

• Information Officer (acc. to § 74a AMG)
• Graduated Plan Officer (acc. to § 63a AMG / EU-QPPV)
• Responsible Person for Wholesale Trading (acc. to § 52a AMG)
• "Qualified Person (acc. to § 15 AMG)
• Responsible Person for Narcotics Trading (BtMV) (acc. to § 5 BtMG)"