DOSSIER

Registration dossier preparation, compilation and Review (Regional specific formats e.g. ACTD, CTD, LATAM, CIS etc.). Filing to domestic (CDSCO) and International regulatory bodies.
Preparation of Package inserts (Patient information Leaflet, Prescribing information), Summary of Product characteristics (SPC).

IMPORT

Import Registration Services - (Form-10) Finished formulations, Bulk Drugs, Medical Device, Diagnostics, Test License (Form-11).

EXPORT

Export Services - BE NOC, Shelf Life Extension

CDSCO

NDA, IND Approvals from CDSCO
Medical Writing Service for Non Clinical and Clinical summary reports for clinical trial and Bioequivalence Studies.
Association with CDSCO and EU/US approved centre for Bioequivalence and clinical trial conduction

MEA & EMBASSY

Ministry of External Affairs and Embassy Document Attestation.