We support pharmaceutical and medical device companies in implementing compliance rules for working with doctors and medical institutions. The high level of regulation in the life sciences sector makes it necessary to identify and minimise compliance risks.
This applies in particular to the following areas
- Correct classification of products (differentiation between medicinal products/medical devices/cosmetics/food)
- Conducting clinical studies and observational studies
- Implementation of legal requirements for medicinal products
Approach and Range of Services
Approach
All players in the healthcare system, especially doctors, are expected to think and act independently for the best benefit of patients. This has a major impact on the room for manoeuvre of pharmaceutical and medical device companies.
In order to be able to use this in a legally compliant manner, we support companies in the life sciences sector in the planning and implementation of compliance programmes and in the creation, drafting and negotiation of legally compliant contracts and collaborations with doctors and medical institutions.
A large number of national and international industry codes (EFPIA, Med Tech Europe, BVMed Code, FSA and AKG regulations, etc.) as well as professional and social law requirements must also be observed.
Range of Services
Our range of services includes the following compliance-relevant topics:
- Examination of co-operations of the pharmaceutical and medical device industry with physicians and medical institutions
- Review of all types of advertising (print media, social media, radio and television, trade fair appearances)
- Preparation of standard contracts for co-operation with doctors and medical facilities
- Creation and implementation of internal company guidelines and processes (e.g. social media guidelines)
- Carrying out employee training (e.g. for sales staff)
Your Contact
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Munich , Germany
- +49 (0)89 620 306 245
- Email Dr Cord
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