Regulatory Affairs

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Providing first-class regulatory services to help expedite drug development within a complex and dynamic environment.

The preparation of applications to IECs/IRBs is a specialized regulatory task. Founded in 1996 as a regulatory affairs consultancy, Novotech has a strong tradition of providing regulatory affairs services to the pharmaceutical and biotechnology industries. We have senior regulatory specialists dedicated to managing the ethics approval and regulatory process to ensure efficient and timely start-up of all studies.

Our experience in regulatory affairs covers most major institutions in the Asia Pacific countries in which we operate.

Ethics Only Capability

As one of the few regionally based CROs with a dedicated ethics clearance service, Novotech is also able to undertake individual projects limited to managing the ethics approval process only, if you prefer to undertake project management and monitoring responsibilities.