Regulatory Affairs
Whether it’s a clinical trial or a medicinal product – we cover all areas for approval.
We are proud to be listed in the BIOCOM directory and work closely with the Research Association of Drug Manufacturers (FAH) and the Institute of Clinical Research.
Mediconomics takes over your clinical project entirely or in parts. For instance: application, project management, monitoring, statistics and preparation of the final report.
Our regulatory operations are grouped into Clinical Trial Regulatory Affairs and Drug Regulatory Affairs:
We proudly provide all services for clinical trials (phase I-IV), project management, data management, medical writing and pharmacovigilance. Essential steps need to be addressed, including design performance and safety, business economics, risk management and regulatory requirements. With these considerations in focus, we adhere to the criteria in ISO 9001:2015, which address a system of quality management standards. You can delegate the complete project or parts of the development process, and we will generate an individual road map that fits your product and helps to circumnavigate delay causing pitfalls with such vital ventures.
The certification procedure for medical devices belongs to our day-to-day business. The process is becoming more and more demanding and faces increasing requirements for proving the suitability of a potential medical device. Nevertheless, innovations ought to be marketable in a commercially acceptable period of time. For you to remain competitive, Mediconomics’ sister company Medicoforum GmbH (certified acc. to DIN EN ISO 13485:2016) takes care of the correct classification, optimisation of the technical documentation and complete certification process.
Our services include:
Our services include: