IT IS UP TO US ALONE WHETHER WE BUILD A BRIDGE OUT OF MANY STONES LYING ON THE WAY.
When it comes to the approval of pharmaceuticals, chemicals, foodstuffs and cosmetics, you are faced with increasingly stringent requirements. CE certification and recertification of medical devices according to the new Medical Device Regulation MDR is a major challenge. tpi consult AG has the expertise and experience to support you in these tasks. We are certified as EUROTOX reg. toxicologist.
BfArM, PEI, EMEA and FDA and various Notified Bodies are our partners for drug approval and CE certification.
We create Common Technical Documents (CTD and e-CTD) for you.
We have great expertise in the preparation of Biological Expert Reports BER and Clinical Expert Reports CER for medical device certification.
Our core competencies are in the fields of toxicology, pharmacology and immunology.
The planning, support and execution of preclinical and clinical trials is provided by tpi consult AG.