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FULL PROCESS OVERVIEW

QP declaration

Medical writing
Scientific advice RA Submission Strategy Distribution Licensing

Formulation Preclinical and clinical Marketing Authorization Batch Release Batch
Development strategy Application Testing

Product Preclinical Clinical Regulatory Post approval Commer-
Early development Registration
development Phase Phase approval (LCM) cialization

API Preclinical Clinical GMP Mock
Variations Renewal
Manufacturing Studies studies, Audit GMP Transfer Withdrawal
API Sourcing BE studies Training P&R

GMP Mock
Audit GMP Pharmacovigilance
Training

RESEARCH & DEVELOPMENT APPROVAL COMERCIALIZATION