Regulatory & Compliance

Regulatory & Compliance ensures that pharmaceutical products meet global safety, quality, and efficacy standards set by regulatory agencies like the FDA, EMA, WHO, and ICH. Key areas include:

Regulatory Affairs

Manages FDA submissions, EMA filings, NDA/BLA approvals, and global market authorizations.

Oversees GMP compliance, CAPA management, audits, and deviation investigations.

Ensures adherence to 21 CFR Part 11, data integrity, and regulatory inspections.

Quality Assurance (QA)

Compliance & Risk Management

Regulatory & Compliance is essential for maintaining market approvals, patient safety, and industry trust in pharmaceutical manufacturing.

Pharmacovigilance & Safety

Monitors adverse drug reactions (ADRs), post-market surveillance, and patient safety reporting.