Role of Regulatory Affairs Department

• 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.