Our regulatory affairs services for clinical trials
- Regulatory advice and support
- Approvals, changes, notifications and reporting
- Coordination and communication of/with competent authorities, ethics committees and local authorities
- Insurance processing
- Deadline monitoring
Our regulatory affairs services for medicinal products
- Scientific and regulatory consultations
- Management and submission of national and international eCTDs
- Preparation and implementation of approval procedures (CP/DCP/MRP/NP)
- Maintenance and life cycle management of approvals (change notifications, extensions, etc.)
We offer you services for planning, obtaining and maintaining licenses in the pharmaceutical sector
The sooner, the better
Good advice right from the start ensures success
Our 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 a good chance of obtaining regulatory approval.
Always at your side in every situation
In addition, marketing and advertising appearances to present the product are monitored to ensure that they are technically correct. If undesirable side effects occur with medicines, communication with the authorities is handled. Compliance with all relevant regulations and laws and timely communication with the authorities must be ensured at all times.
Whether it's a clinical trial or a drug - we cover all areas for you.
Ensuring the efficacy and safety of pharmaceutical products is subject to strict regulatory requirements in all phases of pharmaceutical development. At Mediconomics, we can draw on a wealth of experience in approval procedures and are very familiar with the special features of the field of regulatory affairs.
We are also actively involved in promoting education and training in this field and are registered with the German Society for Regulatory Affairs (DGRA). Our regulatory activities are divided into regulatory affairs for clinical trials and medicinal products.
Locations
Maps
contact@mediconomics.com
+49 (0) 511 560 998-0
Call us
And what can we do for you?
Dr. (MD) Uwe Albrecht,
FIBMS, FFPM (Dis.), FICR, CSci
CEO
Headquarters
Hanover
FAQ – frequently asked questions
Regulatory Affairs deals with the market approval of new pharmaceutical products and regulatory affairs for clinical trials and medical devices. It plays an important role in ensuring that the products to be approved meet the requirements of the regulatory authorities as fully as possible.
Regulatory Affairs involves the optimal preparation and implementation of approval procedures for medicinal products. This includes, for example, the preparation of approval dossiers, advice on pharmaceutical legislation, and the management and submission of Electronic Common Technical Documents at national and international level. The process is accompanied from the idea through development to the market launch of the product.
Regulatory Affairs provides support in obtaining approvals, drawing up concepts, monitoring deadlines, processing contracts and insurance, and providing regulatory support and advice for clinical trials. This is done in close coordination with the related departments and the responsible authorities.
Support in the area of regulatory affairs is offered by service companies or CROs such as Mediconomics, which specialize in this area and have the necessary expertise to support the approval process in the best possible and most time-saving way.