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 medicinal products, chemicals, foodstuffs and cosmetics, ever higher demands are being placed on you. The CE certification and recertification of medical devices according to the new Medical Device Regulation MDR is a big challenge. tpi consult GmbH has the expertise and experience to support you in these tasks. We have the certification 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 GmbH.