Communication with regulatory authorities
For companies within, but especially outside the European Union (EU), Kinesis can assist with the interpretation of EU regulations, can act as the sponsors’ representative in communications and meetings with EMA and local EU authorities. Kinesis can organize submitting a full eCTD dossier. and convert existing submission dossiers to meet EU requirements. For communication with regulatory authorities outside the EU, Kinesis cooperates with local contract research organizations (CROs).
Answering questions from authorities
Kinesis can assists in formulating the answers to difficult question from the authorities. In these assignments, Kinesis focuses on negotiating with the authorities to gain approval of the sponsors’ objectives.