Regulatory Affairs

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Regulatory Affairs

Our Regulatory Affairs department has competency in handling multiple regulatory activities from clinical trial applications to marketing authorization. Our team has worked on clinical trial permission and marketing authorization of Drugs, Biologics and Medical Devices. Our team with their expertise in regulatory consulting and help to address the requirement of sponsors, investigators and also to the regulators to ensure compliance with applicable regulations. We review regulatory requirement in detail, suggest ideas and provide support for quicker development at every step. Our regulatory expertise ensures detail project planning and strategies to meet legislative requirements and this helps in improve efficiency, accelerating timelines and reduce delays.

 

We offer a full range of regulatory services from designing of overall regulatory strategy to marketing authorization and post approval life cycle management. We also have regulatory liaising expertise with deep knowledge of legislation and regulatory environment.

We are specialized in managing the following activities