Regulatory Affairs

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 Regulatory Affairs department provides comprehensive support for the approval of products and develops strategies to facilitate the achievement of your pharmaceutical goals.

The sooner, the better

Obtaining regulatory approvals for the development, manufacture, distribution and marketing of a medicinal product requires the control and organization of all necessary activities – this falls within the remit of Regulatory Affairs.

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.