A recent report by Deloitte identified seven key regulatory issues faced by the Life Sciences industry

1. Life science companies often lack an enterprise-wide view of compliance risk
Globally, governments
and agencies have created a hugely complex regulatory environment. As a result, companies within the life sciences sometimes struggle to understand, and often lack, an enterprise-wide view of compliance risk.

2. Big Data’s role in compliance is often overlooked
Much of the analysis and reporting within life
sciences is
based on historical data.  The application of advanced data analytics techniques would assist to identify and quantify new and/or emerging risks.

3. The competitive advantages of ethics-driven cultures are being recognised
Culture change programmes
will be a critical success factor.

4. Companies with the most mature compliance functions will win the talent war
The compliance skill set is changing. Successful companies will be those that can develop and sustain their employees knowledge of compliance to meet the increasing demand for, and changing nature of, compliance skills.

5. A lack of dedicated, local compliance resources presents a significant risk for global companies
As levels of regulation increase in smaller, local markets, the appropriate compliance resources are required to ensure compliance standards are not compromised. 

6. Major opportunities exist to optimise compliance effectiveness and efficiency
Continuous readiness models are more efficient and would drastically lower overall compliance costs.

7. Leading companies build regulatory engagement into their innovation models
We, as an 
industry need to take the initiative to negotiate a balanced position with regulators.

 

As the study demonstrates, the regulatory environment is ever changing, driven by increasing regulatory requirements, increasing development costs and times, and market pressures impacting pharmaceutical and food industries. Regulatory issues influence decision-making throughout the product life cycle - at every stage of development, distribution, marketing and post-market monitoring.  

Purolite implements control documentation and processes at every level to ensure regulatory support to customers that are using our products.  For Life Sciences products, Regulatory Support Files (RSF) are available. Regulatory Support Files provide direct and detailed information on performance, stability, extractable compounds, and analytical methods for each resin.

Our full regulatory brochure for our Chromalite®, Lifetech™ and Purolite® PAD and Adsorbent ranges, is available to view below: