Convert compliance from cost centre to competitive edge

Maintaining compliance can feel relentless. Each time life sciences companies think they are on top of everything, specifications are updated or a new wave of change comes along. Regulatory work is too often viewed as a necessary evil, something to satisfy the authorities and minimise business risk. Beyond this, organisations have not typically looked for the real strategic benefits that are in plain sight.

Companies are moving away from processes built around manually filling in paper or PDF documents for each unique regulatory reporting requirement, toward building rich, dynamic databases whose contents can be re-purposed many times over. A definitive central resource where all of the required information (and more besides) can be collated, checked, refined and updated – so that anything else that happens thereafter with that information is, by default, correct and compliant.

Basing compliance activity on structured, ready-to-go data

The pharmaceutical sector has tended to be slow to adapt to the benefits of this approach - because of the legacy data, systems and processes companies have had to unravel first. But basing compliance activity on structured, ready-to-go data, in a consistent format, means the latest, correct information can be called up and prepared at speed using the latest digital tools to ensure efficient data exchanges with authorities, with full details/a clear line of sight across every products right along its lifecycle – for reliability, traceability and protected data access.

Traditionally, audits, inspections, complaints handling, and pharmacovigilance, have put the spotlight on non-compliance. But what if positive action and pre-emptive compliance were made business differentiators? If they became a signal to the market, and to customers/patients, that a company has an enriched sense of public duty, of ‘wanting to do the right thing’? Amid the continued COVID disruption, and more recently the Black Lives Matter movement, there is an expectation that businesses review their culture, policies, and practices. Markets and customers have heightened sensitivity to whether companies are ‘walking the talk’, or whether everything they do is secondary to making a profit.

In life sciences CMC and, more recently, safety disciplines, new concepts have been developed by adopting a proactive rather than a defensive approach to compliance. The ‘Quality by Design’ initiative in CMC makes it possible to incorporate potential non-compliance risk in the development phase of the manufacturing process, for instance. The idea is to establish methods to increase robustness, minimising post-market manufacturing inspection impacts. And, by extension, improve the patient experience by bringing better products to market, faster.

Companies can still look for cost efficiencies in all of this. Rather than lament next waves of regulatory demands, smart companies will look out for them – and be ready. This means maintaining active ‘compliance intelligence’ - proactively identifying and anticipating trends in emerging rules, laws, or good practices.

We generally advise the relevant team within the company - or a suitable partner - to conduct a risk assessment within the context of the organisation’s current business model, highlighting points to anticipate as new requirements appear on the horizon.

Once official requirements are published, the next task is to perform a gap analysis identifying all the potential implication arising. These might range from a simple but time-consuming review of a number of inter-related documents and data that will be involved/affected, to potential additional technical and scientific work (eg to replace a banned ingredient/questionable material by another) - and then gain approval from the authorities for any changes made.

Where a company has adopted a proactive approach to compliance - better still  harnessed compliance as a lever to optimise the way it develops and manages its products - then the really smart thing to do is capture the lessons learned, perform a risk assessment and engage in process changes through a controlled transformation process.

Forewarned is forearmed

Once life science companies begin to realise the benefits of using compliance data and activities to drive the business,  it is inevitable that compliance activity will become higher priority. It is not unusual for companies who have seen the contribution of a proactive compliance approach to business success and patient outcomes, to set up a dedicated team or even outsource activities to make sure they are getting maximum benefit. The view of regulatory compliance as a tiresome overhead is increasingly characteristic of companies that are failing to exploit the opportunity to gain competitive edge.

About the author

Xavier Duburcq is ProductLife Group’s CEO. A pharmacist, with a PhD in Immunology, Xavier was involved in his early career in the development of new medical devices for the detection of hepatitis, HIV, malaria and other blood viruses at Sedac Therapeutics and Biorad.