What does Regulatory Affairs do?
Regulatory Affairs (RA) makes sure every medicine reaching patients is safe, effective, and legally approved.
Responsibilities of the RA member:
- Prepare and submit technical data.
- Communicate with regulatory authorities of CDSCO, USFDA, EMA
- Handle labelling, batch records, and drug master files.
- Ensure Good manufacturing practice compliance, audits, and regulatory updates.
Why RA matters?
- Ensures patient safety through document validation.
- Accelerates global market access for drugs.
- Reduces delays, recalls and penalties.
- Maintains brand credibility and legal security.
Domain and Responsibility:
Formulation R&D : Ensure trial data is compliant.
Quality Assurance: Good Manufacturing practice, Change control
Clinical Trials : Ethics approval, protocol submission