The Regulatory Affairs (RA) Department ensures compliance with regulatory requirements, facilitates product approvals, and manages communications with regulatory bodies.
Product Registrations and Approvals
Prepares and submits registration dossiers for drugs, generics, or biosimilars.
Ensures compliance for product approvals.
Regulatory Compliance
Maintains up-to-date knowledge of regulations and implements standards like GMP, GCP, and GLP.
Labeling and Packaging
Ensures product labels and packaging meet regulatory standards.
Post-Marketing Surveillance
Monitors product safety post-launch and manages recalls if needed.
Communication with Authorities
Serves as a liaison, handling queries and providing documentation to regulatory bodies.
Regulatory Strategy
Advises on regulatory aspects during product development and ensures alignment with market access requirements.
The RA Department supports product compliance, safety, and effective regulatory communication throughout the product lifecycle.