Regulatory Requirements:

KLINTRA’S ‘ Regulatory coordinators’ assists in regulatory procedures starting from strategic planning to submission with focus on quality,cost and time.

We ensure speedy approval of submissions,dynamic updates on guidelines specific to document handling procedures,electronic submissions, 21 CFR part 11&trial specific regulatories. A critical aspect of our responsibility to our clients is to ensure compliance with the changing regulatory guidelines and requirements as well as adapting our services to the emerging trends in submission procedures and technologies.

We accomplish this by providing interdisciplinary strategy planning to obtain the most effective and efficient regulatory pathway towards required regulatory authorizations. Our experience in handling a wide variety of regulatory challenges help clients in meeting challenging timelines and budget expectations. Work flow and process are designed to provide cost effective and efficient project management solutions towards regulatory authorizations. Our ability to assist clients in obtaining appropriate approvals is supported by a deep understanding of and experience in dealing with the complexities of Indian regulations. We are capable of providing services as complete and stand-alone consultancy.