Regulatory compliance

Regulatory compliance

Pharmaceutical rules and regulations in Europe are complex and constantly changing. Lionpharm can help you to stay in compliance with all the legislation applicable for your company and product portfolio. We also provide personnel support for the various required drug law functions that need to be present in a registered pharmaceutical company. In case you need such a temporary or permanent expert, we can provide personnel with the expertise needed.

1. Regulatory advice
   We have come across many regulatory situations in Europe that you need to be aware of. So just ask us - we most probably have the answer.
2. Qualified Person (QP)
   The Qualified Person is required for manufacture and quality control of medicinal products.
3. Qualified Person Pharmacovigilance (QPPV), local and EU
   This person is responsible for all pharmacovigilance activities in a company.
4. Responsible person wholesale
   In some countries an expert with specific knowledge and practical experience is required for the wholesale distribution of medicinal products.
5. Controlled substances officer
   This responsibility is similar to the responsible person wholesale in the field of controlled substances (“narcotics”).
6. Information officer
   In some countries an expert with specific training is required for the control and release of published text material related to marketed medicinal products.