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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, and can 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. Kinesis’ track record in regulatory affairs covers over 20 different therapeutic areas. Sponsors can rely on Kinesis’ expertise and high quality standards for any type of application, whether the compound is chemically synthesized, a biological or biotechnological product or a traditional herbal medicinal product (THMP). For all steps in the regulatory process, a check for the most recent formats and guidance provided by ICH, EMA, FDA or national authorities is performed. Kinesis is committed to the sponsors’ timelines for submission.