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Regulatory and compliance management
The pharmaceutical and life science industry is one of the most strictly regulated sectors in which to operate. Every aspect is tightly controlled and requires verifications to ensure high quality and compliance with regulations and (external) expectations. In addition, the regulations are closely monitored by both the authorities and stakeholders in the sector; companies must be vigilant to ensure they remain in compliance.
Given the highly regulated character of the industry, shortcomings or failures may have a major, even critical, impact on the business. Yet rather than viewing the demands of regulatory and compliance as an obligation, approached and managed correctly, these aspects can actually enhance both the performance and the perception of a modern business.
In order to realise the advantages, however, the importance of regulatory and compliance should be embedded in the company culture at all levels. By helping you establish or restructure your internal procedures appropriately, PwC can bring these benefits to the fore and maximise the impact on your organisation, now and in the future.
Regulatory: realising the benefits of a modern approach
The regulatory environment for pharmaceutical and life science companies exists for a reason. It ensures that available treatments are safe and reliable, and that all the appropriate procedures have been followed, from their initial conception and entire lifecycle. The applicable regulations set out the standards to be met.
- Start-up companies
- Established healthcare organisations
Start-up companies
The regulatory environment and start-up companies
For start-up and early-stage research companies, meeting regulatory demands may seem an issue for a later stage in their development. In reality, however, recognising the importance of embedding ethical and regulatory-compliant approaches in the company processes is something that should be embraced from the outset. Establishing the correct structure – at a level appropriate to the current state of development – will inevitably bring dividends in the longer term.
Established healthcare organisations
The regulatory environment and established healthcare organisations
Larger, established companies are aware of the demands of regulatory and compliance, and will already have processes in place. However, these processes may be the result of organic growth and mergers and acquisitions, leading to a proliferation of processes that may be incompatible or are collecting the wrong information. As a result, these may be suboptimal and unlikely to extract the inherent value of a modern approach to regulatory and compliance.
Making quality and regulatory compliance a shared goal requires the correct mindset and behaviour, with a great deal of interaction between regulatory, compliance and business functions. PwC can assist companies in making this approach a reality, by helping you put in place the structure you need, on a scale that is appropriate to your current situation.
Compliance: the advantages of a modern approach
Historically, compliance has been viewed as an obligation and part of the cost of doing business. However, as attitudes to, and expectations of, corporate behaviour have evolved, so has the importance of the Compliance department within companies. The function is becoming the ‘ethical compass’ of an organisation, safeguarding the organisation’s values.
Adopting this ethical perception of compliance is significant. It means that compliance is not simply a legal obligation, but rather a representation of the values of the company. Embedding compliance principles in your organisational processes enhances the business by ensuring it takes a more proactive approach.
How PwC can help your approach to compliance
To be a successful and competitive organisation these days, it is important to have a culture of compliance embedded in the company. This is a proactive approach that will only enhance inspections from authorities.
PwC can support you both with analysing your current compliance DNA in the company and help to implement a compliance centred organisation. We will assess where you currently stand, identify what you need to change and define how to get you there quickly.
We can help you put in place the required systems and technology to provide the compliance function with the information it requires to be truly effective in its role. PwC can assist in driving the required change in mindset in your people to make them work effectively within this approach.
Managing compliance problems
The regulations covering the pharmaceutical and life science industry are rarely static, with revisions and updated legislation commonplace. PwC can help you adapt to any revised demands quickly and effectively, potentially providing you with a competitive advantage.
PwC can also help deal with situations such as enforcement actions. In the circumstances where, for example, your company receives a letter from the regulators, PwC will help analyse the nature of the problem and ensure you act appropriately to resolve the issue and prevent it happening again.
Compliance is a shared goal in a quality, regulatory and ethical context. The correct mindset and behaviour, with a great deal of interaction between the supporting and business functions is required. PwC can assist companies in making this approach a reality, by helping you put in place the structure you need, on a scale that is appropriate to your current situation.
The passage to being able to leverage regulatory and compliance as a business benefit can take time. As a result, companies find themselves at different stages in their journey.
Future Trends: PwC Thought Leadership
If you want to know more about PwC and how we view the future of healthcare, read our thought leadership contributions.
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