Regulatory Affairs: Whether it’s a clinical trial or a medicinal product – we cover all areas for approval.
The Regulatory Affairs department provides comprehensive support to facilitate the approval of products and develops strategies to ensure the achievement of common goals.
Obtaining regulatory approval for the development, manufacture, distribution and marketing of a medicinal product requires careful planning, control and organisation of all necessary steps – this falls within the scope of Regulatory Affairs.
At Mediconomics, Regulatory Affairs specialists work closely with the research and development departments at all times and provide advice right from the conception of product ideas to ensure that medicinal products and medical devices have the best chance of obtaining regulatory approval.At Mediconomics regulatory approval is not merely an after thought.
Following approval, marketing and promotional tools that introduce the product are monitored to ensure their scientific accuracy. Should adverse events occur, our experts handle communication with the appropriate authorities. Compliance with all relevant regulations and laws, as well as timely communication with authorities, are always ensured.
Whether it’s a clinical trial or a medicinal product – we cover all steps of the approval process.
Ensuring the efficacy and safety of pharmaceutical products is subject to strict regulatory requirements at all stages of pharmaceutical development. At Mediconomics, we are experienced with various specialities and have reached approval in a wide range of procedures.
In addition, we are actively involved in promoting education and training in this field and are therefore registered with the German Society for Regulatory Affairs (DGRA). Our regulatory operations are grouped into Clinical Trial Regulatory Affairs and Drug Regulatory Affairs as outlined below:
Clinical Trial Regulatory Affairs:
- Regulatory consultancy and advice
- Approval, amendments, notifications and reporting
- Coordination and communications of/with competent authorities, ethics companies and local authorities
- Insurance handling
- Deadline monitoring
Drug Regulatory Affairs:
- Scientific and regulatory advice meetings
- Management and submission of eCTDs, nationally and internationally
- Preparation and conduct of authorisation procedures (CP/DCP/MRP/NP)
- Maintenance and life-cycle management of marketing authorisations (Variations, Renewals, etc.)