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International Regulatory Affairs
Dossier Preparation

We provide services for cGMP,Drug Master File(DMF) ,Validation, Training and Documentation, Mock audits as per regulatory requirements, replies to deficiency letter by regulatory agency ,CTD preparation ,making all systems adhering to IR requirements & generation of technical data inline with the regulatory requirements and submission of dossiers for various country specific requirements managed by international level team.

For Responsive, Personal, Efficient and strategically sound regulatory services connect to Prism Consultancy



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