OUR REGULATORY AFFAIRS SERVICES:

IGRS has handled many regulatory submissions, in different countries, on behalf of client companies. These include Gap analysis of dossier, product development CTD dossier, Analytical method validation, Bio-waiver documentation, Documents review / assembly / compilation and submission for marketing authorizations. eCTD is an electronic format which will replace the paper designed CTD eventually.

  Global Product Strategy Planning
  Product Development
 Technical Due Diligence
  Quality Management
 Regulatory
 Contract Manufacturing & Marketing
  Validation
  Pharmacovigilance
  Bioequivalence
  Clinical Writing
 Audits
  Translation
  Patents
  Liaison
  Training & Seminars