Global Capabilities

NORTH AMERICA

USA(FDA)

ANDA (Abbreviated New Drug Application)

  • Regulatory Guidance for product development to file 505(j) and 505(b)(2) ANDA
  • Module 1 to Module 5 Scientific writing as per the UDFDA guidance
  • Draft Labeling preparation
  • Obtaining FEI, DUNS and Labeler Code
  • Support for US Agent
  • CTD format to eCTD conversion
  • Support in ANDA filing directly to USFDA through ESG account
  • Query response
  • Annual Product Review Submission
  • Post Approval Amendment (PAS) and CBE 30 application

Drug Master Files (DMFs)

  • Technical data review and DMF writing as per US CTD
  • Direct submission to FDA through ESG

MEXICO (COFEPRIS):

  • Regulatory Support in identifying product grid based on regulatory mandates
  • Technical dossier writing considering COFEPRIS requirements and past queries
  • Dossier submission to COFEPRIS
  • Query response
  • Product Approval