Michaela Merz

PwC’s Pharma & Life Sciences Regulatory Radar

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Increasing regulatory challenges

The pharmaceutical & life sciences industry, a long-standing, innovative and successful industry, needs to function in an increasingly challenging market environment. Regulation is one of the main reasons for this. In an increasingly interconnected world where more and more sophisticated pharmaceutical (e.g. genetically engineered, and biologicals, orphan drugs), Medtech as well as nutrition products are being developed, public scrutiny and ultimately legal frameworks are tightening. Governments and regulators are adopting more regulations in order to meet the requirements of technological advancement and changing social conditions (e.g EU GMP/GDP Annex 21, Annex 6 and 16 for clinical trials and the new Swiss “Arzneimittelverordnung”). Given the vast quantity of regulations, there is an inherent risk of missing out on critical topics or taking the required action too late. Therefore, the pharmaceutical & life sciences sector will have to be vigilant and adapt to the constantly changing regulatory landscape.

 

The digital solution to sure you are fully informed

The Regulatory Radar is our response to the regulatory avalanche. With our Pharma & Life Sciences Regulatory Radar, you will not miss out on any new regulations concerning clinical trials and commercial (e.g. R&D products and precision medicines or to reimbursement of medicines through the social security systems. At the same time, you will receive a tailor-made solution that analyses regulatory initiatives and draws your attention to the need for potential action.

Based on our global presence, PwC monitors through its national and international network the publications and updates of the relevant authorities and provides a detailed overview of the latest regulatory developments in various jurisdictions (e.g. US, EU, Switzerland). The Pharma Regulatory Radar measures the impact of regulation on businesses and enables a periodisation in terms of measures. We cover the entire cycle of a regulation, from its legislative formation process, entry into force to its impact on businesses. We thereby not only help you to save money and allocate resources most efficiently, but also provide you with the benefit of our practical experience and knowledge to highlight a way forward.

 

Your Benefits

  • Save costs and resources
  • Consolidated supervision
  • Tailor-made solution matching your corporate structure
  • Clear prioritisation
  • Profit from our knowledge and longstanding experience
  • Free up time for key strategic issues

 

Regulartory Radar – Key features

  • Regulatory updates
  • Early warning system
  • Impact analyses, reports and expert advice on corresponding action
  • Forward-looking tool
  • Easy digital access
  • Possibility to customise the tool according to your needs

 

For more information please contact:

Dr. Sandra Ragaz-Fumia, Partner, PwC Schweiz
Tel. +41 58 792 44 69
E-Mail: sandra.ragaz@ch.pwc.com

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