Regulatory

Our Regulatory team consists of highly qualified personnel engaged in providing data required as per the Regulatory Guidelines of the different countries. Our Regulatory team can provide complete support to register the Products.

  • ACTD Dossiers
  • CTD Dossiers
  • Dossiers as per specific Guideline of all countries
  • Bio-Equivalence Studies with GLP certified clinical centres (BE Study)
  • Pharmacokinetic Studies
  • Drug Master Files (DMF)
  • Site Master File
  • Electronic Submission of Dossiers with all supporting documents
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