Regulation in Life Sciences

Change continues to shape the regulatory landscape for life sciences. Uncertainty prevails where markets shift and stakeholders try to understand change — making the need to plan more urgent than ever. From increased scrutiny of data integrity to the tracking of medicinal products, to changing political landscape and policy changes, today’s shifting regulatory priorities will need to be front and center as you develop your compliance strategies, actions and investments.

By developing strategies to address regulatory compliance, life sciences companies should be able to transform compliance activity from a cost to value creating process that delivers sustainable competitive advantage. Deloitte can deliver for you on this journey by supporting the development of your regulatory compliance strategy, performing compliance tasks in partnership with you, and enhancing the maturity of your compliance function.

We can support you in the following areas:

• Third party risk management
• Including Pharmacovigilance/ Post-marketing Surveillance/ Contract Research Organisation Support with the development of the Compliance Programme for your organisation
• Ethics & Compliance – Supporting in achieving compliance and reviewing compliance with EFPIA/ IPHA/ ABPI Codes of Practice
• Computerised System Lifecycle Validation Services
• Support with establishing and reviewing compliance with Pharmaceutical/ Medical Device Industry legislation including:

        - Life Sciences GxP regulations

        - Clinical Trial Regulation (CTR)

        - Medical Device Regulation (MDR)

        - In-Vitro Diagnostic Medical Device Regulation (IVDR)