Validation Quality & Compliance
Pharmaceutical companies operate in rapidly changing environments due to the dynamic nature of global regulatory compliance. Changes in regulations by leading bodies such as the US Food and Drug Administration (USFDA), WHO, CFDA, Health Canada, the European Medicines Agency (EMA) etc. have increased the significance of regulatory compliance management for drug manufacturers. Pharma companies across the globe are required to change their compliance practices to conform to changes in regulations and stringent anti-corruption laws. The US FDA oversees regulatory activity across the globe making pharma & life sciences companies identify quality issues before they impact the production.
With the FDA and other regulators broadening the scope of compliance requirements, it helps if companies have a holistic approach and make regulatory compliance part of the corporate strategy along with competent consultants and service providers proficient with the quality and compliance.