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.)
FAQ – frequently asked questions
What subject areas does Regulatory Affairs cover?
Regulatory Affairs covers the marketing authorisation of new pharmaceutical products and the regulatory aspects of clinical trials and medical devices. It plays an important role in ensuring that the products requiring approval meet the precise requirements of the regulatory authorities.
What is the role of Regulatory Affairs for medicinal products?
Regulatory Affairs encompasses the optimal preparation and implementation of marketing authorisation procedures for medicinal products. This includes, for example, the generation of marketing authorisation dossiers, advice on medicinal product legislation, and the management and submission of Electronic Common Technical Documents at national and international level. We support the process from the initial conceptualisation, through development and to the market launch of the product.
What is the role of Regulatory Affairs in clinical trials?
Regulatory Affairs provides support in obtaining approvals, preparing concepts, deadline monitoring, and contract and insurance handling as well as offering regulatory support and advice for clinical trials. This is done in close co-ordination with the associated departments and the competent authorities.
Who provides Regulatory Affairs support?
Regulatory Affairs support is offered by service providers or CROs such as Mediconomics, who specialise in this area and have the necessary expertise to accompany the approval process in the best possible and most time-efficient way.