Navigating regulatory frameworks is critical to the development, approval, and distribution of pharmaceuticals. This book outlines key concepts in regulatory affairs, including drug registration, documentation, labeling, and compliance with national and international guidelines. It discusses agencies such as the FDA, EMA, and CDSCO, and regulatory pathways for generics, new chemical entities, and biologics. Quality assurance, inspections, and dossier preparation are covered. The book equips pharmacy professionals with the knowledge to manage regulatory submissions and ensure adherence to legal standards in the pharmaceutical industry.
Amara Bello is a legal and policy expert in pharmaceutical compliance, specializing in global regulatory frameworks. With a background in both pharmacy and law, she brings a unique interdisciplinary perspective to drug licensing, post-market surveillance, and regulatory documentation. Amara has contributed to harmonization initiatives across regulatory authorities in Africa and the Middle East. She trains pharmacy professionals in dossier preparation and compliance auditing, and her policy briefs are widely circulated among industry stakeholders and academic regulators.