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

      Strategic Planning

        Complete regulatory strategy planning

        Product development strategy

        GAP analysis and Corrective action plan

        Dossier preparation

        Submission  planning for all stages

      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

      Submission and Tracking

        Filing of all submission

        Submission tracking

        Strategic query resolution