Managing complex regulatory requirements
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:
- How can I manage compliance for in-licensing and out-licensing arrangements in clinical trials, manufacturing and marketing agreements?
- Can a strong compliance and risk management programme co-exist with an emphasis on shareholder value and on being more competitive? Can it be a competitive advantage?
- What is the right organisation model for compliance in a global environment? How do I address country, regional and global risks and compliance program elements?
- Am I approaching compliance in a pro-active mode?
- How can I become more innovative whilst adhering to stringent regulations?
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:
- Regulatory compliance assessments, implementation and improvement in the area of good clinical practices, good manufacturing practices, deontological interaction with healthcare practitioners, computer system validation, eCTD implementation support, pharmacovigilence, ICH Q8, Q9, Q10, etc.
- Regulatory affairs and compliance strategies being aligned with the business vision and innovative concepts such as PAT/QbD, continuous manufacturing, disposable manufacturing concepts, etc.
- Global integrated compliance programmes
- Enterprise risk management programmes
- Develop and deploy simplification, centralisation & standardisation of compliance processes
- Support consistent application of policies and regulations in diverse operating environments and geographies
- Make data accessible for real-time investigations, audits and monitoring
- Specific compliance requirements for medical devices, blood fractionation, biotechnology, diagnostics, nutraceuticals, etc.
- 21 CFR Part 11 consulting services for quality systems, IT systems and IT infrastructure
- Computer system validation consulting services (IQ, OQ,PQ, Vendor Audit, reviewing and creating SOP’s) for key enterprise & automated systems
- Review/assess the existing quality framework, program and systems in line with regulatory standards and guidelines, and provide your organization with integrated compliance dashboard
- Regulatory & compliance audits: system and process audit in line with regulatory requirements, vendor and supplier audit, investigator site audit (FDA GCP & ICH E6), manufacturing facilities and sites auditing (FDA cGMP & ICH Q7A).
Contact us
Partner, Platforms & Industries Leader, Consulting Lead, PwC Belgium
Tel: +32 476 44 53 92
