Medicinal products and medical devices
meyer.science GmbH advises you in the field of medicinal products and medical devices from their development until they are placed on the market. We clarify borderline issues, provide advice on the design of studies for upcoming clinical trials and support you in conducting such trials together with our cooperation partners.
Where authorisation approval is sought for your medicinal products or certification for your medical device, we assist you in compiling the eCTD and the documentation for conformity assessment procedures.
We assist you in requesting scientific advice or protocol assistance from the competent authority either during the initial development of a medicinal product before submission of a marketing-authorisation application or later on, during the post-authorisation phase in order to obtain procedural, regulatory and legal advice.
We also provide guidance with regard to questions concerning reimbursement by public health insurance enterprises. Discuss with us your plans for a benefits evaluation pursuant to Sec. 35a of the German Social Insurance Code (SGB V) if required. In cooperation with the law firm meyer.rechtsanwaltsgesellschaft mbH, we will verify on your behalf whether or not it is necessary to compile a dossier for such a benefits evaluation.
We conduct variations and renewals for nationally authorised (AT, DE, CH), mutually recognised or centrally authorised medicinal products already on the market.
We provide both purely scientific and in-depth legal advice with regard to your marketing materials, by clarifying matters with our cooperation partner meyer.rechtsanwaltsgesellschaft mbH