PwC offers local and international support with regulatory and compliance challenges
PwC recognises the complexities of the different regulatory & compliance requirements, both on a local and international level.
At every part of the product life cycle, from research and development, through manufacturing, distribution and marketing of products, pharma companies must adhere to the regulations from local, national and international authorities.
Recent new regulatory initiatives by different authorities worldwide are the result of the changing dynamics in how pharmaceuticals & life sciences companies operate, low manufacturing efficiency, increased amount of global compliance violations, threat of counterfeiting, need for innovation and many other challenges which the pharma industry is facing over the coming years.
The new regulatory initiatives, such as, GMP’s for the 21st Century, new regulation on process validation, deontological interaction with healthcare practitioners, the critical path Initiative, etc. are becoming more and more harmonised throughout the different worldwide authorities and enable the introduction of new technologies, manufacturing strategies and new business models.
Pharmaceuticals companies have to manage complex regulatory requirements and this requires, in particular, the implementation of strong international compliance programmes which integrate compliance processes and technologies.
Only an integrity-driven compliance and risk strategy will contribute to establishing stakeholders’ trust, avoid the reputational risk, and dealing with questions like:
Our governance, risk & compliance advisors throughout the globe work closely together on the local and international regulatory and compliance challenges which the pharma & life sciences industry is currently facing, such as: