9(4) Me Too Registration

9(4) Me Too Registration

9(4) registration addresses post-approval changes for registered technicals and formulations. We support imported and indigenous products, including registrations of previously approved 9(4) items, ensuring seamless compliance with current CIB&RC requirements.

• Regulatory support for import of technicals and formulations
• Assistance with indigenous manufacturing approvals
• Handling of new and alternate source approvals
• Approvals for new or modified formulations
• Management of endorsements related to packaging, labelling, sources, manufacturing changes, and other regulatory variations
• Rigorous scientific review and regulatory conformity assessment of all study reports
• Post-registration support including amendments, renewals, and ongoing compliance management
• Guidance on managing regulatory variations and alignment with updated regulatory guidelines
• Active coordination with regulatory authorities to ensure smooth processing and timely approvals

Our structured, compliance-driven approach ensures accurate submissions, effective regulatory engagement, and seamless post-registration approvals under the 9(4) pathway.