Medicinal Products - Medical devices
RDA Scientific Consultants provides guidance and support throughout all life cycles of your medicinal products and medical devices.
Is your product still at the development stage?
Then discuss with us possible status issues regarding the product category.
We also advise you about the design of studies for
clinical trials, and together with our cooperation partners offer assistance in conducting such trials. As regards medical devices, we compile the documentation for proceedings in order to evaluate conformity.
Are you planning to gain authorisation for a new medicinal product or certification of a medical device?
We can organize a
scientific advice consultation or a pre-submission meeting for you with the competent authorities.
Have you given consideration to the question of reimbursement by the public health insurance?
Discuss your plans with us with regard to an
evaluation of benefits which could be required under Sec. 35a, Social Welfare Code (SGB), Vol. V.
Is your product already on the market?
We file variations on your behalf and conduct renewal procedures for medicinal products approved via national and European authorisation procedures.
We also examine the scientific and legal aspects of your marketing material in cooperation with the law firm
Meisterernst Rechtsanwälte.
