KPMG Life Science Regulatory Solutions Practice

The KPMG Life Science Regulatory Solutions Practice is an expert advisory group offering regulatory services to Pharmaceutical, Medical Device, and Diagnostics companies globally.

 KPMG’s team of regulatory experts have decades of experience delivering successful services for clients. We offer strategic regulatory advice to life science organizations throughout the product development pathway from early phase development and clinical trial advice to marketing authorisation and maintaining compliance for approved products in global markets.

 Our clients will benefit from the expertise of KPMG - a market leader in Tax, Deals and Advisory, Strategy, Risk and Mergers’ and Acquisitions consulting services and our Regulatory Solutions Practice is a unique and innovative full-service consulting solution.

Global Regulatory Solutions

The KPMG regulatory solutions practice is here to help you navigate development hurdles in countries with regulators. enabling your organization to optimise regulatory submissions strategy and your global dossier to avoid delays and pre-empt regulatory challenges in programs.

Our team of experts has a wealth of experience across critical markets including North America, Canada, EU, Japan, Asia and South America. It is crucial to develop an international strategy at an early stage and to consider local requirements and post-launch compliance including safety considerations maintaining an up-to-date product label globally.

An essential requirement for bringing any product to market is having robust risk management in place from day one. From early clinical trials through to post marketing, the requirements on license holders are many and stringent. KPMG Life Sciences Regulatory Solutions experts can ensure regulatory risk management throughout the product lifecycle is managed in accordance with global regulatory requirements and always in the interests of putting patient safety first.

Activities KPMG can support your organisation with:

Product Development

KPMG’s Life Science Regulatory Solutions Practice is a full-service regulatory and product development consulting group. The specialist team of experienced regulatory affairs professionals offers technical regulatory advisory services throughout the product life cycle for biologics, Cell and Gene Therapies (ATMPs). pharmaceuticals, medical device and diagnostic companies globally. Our centre of regulatory excellence provides life science companies extensive Non-clinical, Chemistry, Manufacturing and Control (CMC) and Clinical development expertise; providing a risk based approach to navigating the regulatory requirements of product development across the EU, UK, US, Asia, South America and the rest of the world and helping life science companies maintain their product licenses across global markets.

Regulatory Product Strategy & Value Proposition

Our regulatory experts have a deep understanding of product development strategy, risk management and the rate limiting steps in product development and launch. We support life science companies to identify optimal Target Product Profiles (TPP) for key assets and to achieve their commercial goals through phase appropriate study design.

Commercial Product Launch

The Life Science Regulatory Solutions Practice at KPMG can offer clients a suite of commercial regulatory and strategy services, for example: early commercial planning and forecasting, innovative marketing and promotions, portfolio value maximisation, innovative access and pricing, integrated go-to-market strategy, patient strategies, regulatory compliance and solutions; and product launch and commercialisation.

Life Science Events

DIA Poster: Why are Clinical Trials Struggling with Diversity

Team members recently attended the DIA Europe 2023 Conference in Basel, Switzerland and presented the following poster on diversity, equity and inclusion in clinical trials.

The Impacts of UKCA and Way Forward

The Life Science Regulatory Solutions Practice hosted a Regulatory Roundtable webinar on 08 March 2023 titled 'The Impact of UKCA and Way Forward'. To view the recording, please click here.

impact of UKCA

The Future of Life Sciences in a Rapidly Changing World

On 17th November 2022, a panel of experts participated in an online event titled ‘The Future of Life Sciences in a Rapidly Changing World’. Panellists discussed challenges and opportunities for the biotech and pharmaceutical industries and the transformational changes that are now becoming possible. The recording is available to watch here.

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