The essential objective of any regulator governing drug development and commercialization is to ensure public safety. The underlying objective of pharmacovigilance is to promote safe and effective use of drug products. The successful development of any product depends on various factors, such as safety and efficacy portfolio, quality of clinical data, appropriate regulatory strategies, and timely submission at each step of approval. After the drug is approved, appropriate risk mitigation strategies and pharmacovigilance processes must be in place to comply with the applicable regional and global regulatory requirements otherwise there might be serious consequences of non-compliance. Therefore, partnering with the companies having strong expertise in handling global and complex regulatory requirements will help ensure inspection readiness and safe and effective use of therapeutic products.