Regulatory Clearances

We have proven records and provide complete solutions and services related to regulatory clearances involving the relevant ministries / departments of the government. The services include:

  • Grant of test license for drugs, approvals of Protocols for BE / CT and issue of final permissions for Manufacturing & Marketing of Bulk drugs & Formulations , Issue of Import license, Export permission for drugs including locally banned items from Ministry of Health.
  • Securing Registration of Manufacturing plant of Bulk drugs and Formulations and Medical devices from Ministry of Health.
  • Drafting papers on behalf of industry for policy formulation by Government & Policy clarifications.
  • Preparing case for norms fixation by (DGFT) Ministry of Commerce.
  • Preparing case for policy relaxation where necessary e.g. Export obligation period extension, grant of advance license etc.
  • We also undertake new project from selection of land till the final NOCs from various government offices for putting up the new units
  • Permissions from various government agencies for new ventures / joint ventures
  • Co-ordination between the company and various organizations for Company Formation , Patents, Setting up a New Manufacturing Unit , Industrial Licenses , Approval of R & D Center and Approvals for GMP and GLP facilities from the relevant ministries / departments of the government.