Our Regulatory Department deals with Regulatory Submissions in and outside India to get necessary clearance from regulatory bodies for the Study. We have collaborators and consultants who are able to get faster clearance from any regulatory body. Genelife Clinical ResearGenelife Clinical Research CROch have the expertise to skillfully handle all regulatory issues across the globe. Genelife Clinical Research Regulatory department is fully equipped to handle IND, NDA (including 505(b)(2)) and ANDA submissions. The services provided by Genelife are:

  • Regulatory Document Compilation according to regulatory needs
  • Strategic regulatory planning for specific countries
  • Design of optimized regulatory strategy for NDA or BLA, 505(b)(2), ANDA, Orphan Drugs, Biosimilars and other regulatory pathways
  • Evaluation, compilation, and representation for IND (or equivalent) enablement
  • Processing of application for importing the Investigational product to the Indian regulatory authorities on behalf of the sponsor
  • Preparing Marketing Applications & Marketing Authorization Applications
  • Customs clearance of the Investigational product