Regulatory Affairs

We understand that 'time is money', so our aim is to assist you with a broad range of regulatory affairs services that can help you in successful submission at the shortest time possible for all the phases of the drug development and approval process

Ø      Strategic Planning

·        Complete regulatory strategy planning

·        Product development strategy

·        GAP analysis and Corrective action plan

·        Dossier preparation

·        Submission  planning for all stages

Ø      Relation Development and Interaction

·        Complete planning of regulatory agency interaction

·        Interaction/s with regulatory agencies

·        Assessment of issues, its analysis and resolution

·        Creation of operational link between regulatory agencies and sponsor

Ø      Submission and Tracking

·        Filing of all submission

·        Submission tracking

·        Strategic query resolution