Clinigen acquires Kinesys Consulting to bolster regulatory affairs expertise

CLINIGEN ACQUIRES KINESYS CONSULTING TO BOLSTER REGULATORY AFFAIRS EXPERTISE

Acquisition will give Clinigen expanded capabilities to help its clients navigate the complexities of pharmaceutical development and commercialisation

LONDON, UK, 6 August 2024 - Clinigen, a global leader in specialist pharmaceutical services committed to ethical access to medicines, today announces the acquisition of Kinesys Consulting, a provider of strategic regulatory affairs, regulatory/medical writing, and medical devices services for the pharmaceutical and biotechnology industries.

This strategic acquisition strengthens Clinigen's ability to offer clients comprehensive high value services across the entire drug development and commercialisation lifecycle. From early development to post-marketing support, Clinigen now provides a truly seamless path to market, bringing them closer to their vision of a world where access to medicine is global by design.

This acquisition marks the latest milestone in Clinigen's strategic growth journey and evolution towards becoming a premier global provider of comprehensive high-value services to the pharmaceutical and biotechnology sectors. Following the acquisitions and successful integration of Ascenian Consulting and Drug Safety Navigator, the acquisition of Kinesys Consulting further strengthens Clinigen's position as a foremost full-service partner to the life sciences industry.

Kinesys adds valuable expertise in regulatory strategy and execution for drugs and medical devices, perfectly complementing Clinigen's existing capabilities in regulatory affairs, pharmacovigilance, medical information, clinical trial services, licensed and unlicensed distribution, managed access, and commercialisation, strengthening Clinigen's ability to deliver exceptional value to clients. This combined expertise allows Clinigen to offer clients an efficient path to market with enhanced development solutions, helping them to overcome regulatory hurdles and expediting patient access to new therapies.

The Kinesys team of experts will integrate into Clinigen's Lifecycle Services division, enabling the division to help drive innovation and efficiency in pharmaceutical development. Clinigen's Lifecycle Services division offers a comprehensive suite of services supporting the entire drug lifecycle, from development to commercialisation, including pharmacovigilance, medical information, and regulatory affairs.

Kinesys also brings a highly respected scientific and regulatory advisory board, comprised of seasoned industry veterans, including former regulatory agency assessors. Their substantial experience in drug development within the biopharmaceutical industry will be invaluable in navigating the ever-evolving regulatory landscape for better client success.

Clinigen was advised on the transaction by BDO LLP and Stevens & Bolton LLP, while Ernst and Young LLP and JMW Solicitors LLP acted as financial and legal advisors, respectively, to Kinesys Consulting.

Clinigen CEO Jerome Charton comments:"At Clinigen, we're dedicated to ensuring everyone has access to the treatments they need, and this acquisition unites Clinigen's commitment to healthcare equity with Kinesys' specialised expertise, solidifying Clinigen's position as a life sciences leader. By combining the expertise of Kinesys with our existing services, Clinigen will be better positioned to achieve our mission of accelerating the development and delivery of life-saving treatments to patients worldwide. This move underscores our commitment to helping our clients navigate the complexities of developing and commercialising drugs and medical devices, bringing innovative therapies to patients faster."

Co-founder Kinesys Consulting Elaine Murphycomments: "At Kinesys, we specialise in guiding clients through the intricacies of regulatory strategy and execution for drugs and medical devices, as well as providing a high-quality medical/regulatory writing service. This strong foundation allows us to support our clients throughout the entire development journey. By joining Clinigen, we're excited to offer both our existing clients and Clinigen's a seamless path from navigating initial regulatory hurdles to achieving successful market access."

Co-founder Kinesys Consulting Gerry McGettigan comments: "Clinigen's commitment to improving access to crucial treatments for patients across the globe make them the perfect partner to take Kinesys into its next exciting chapter. This partnership unlocks new horizons for Kinesys. By joining forces with Clinigen, with its leading expertise across the entire drug development landscape, we can create a truly powerful force for accelerating patient access to life-saving treatments on a global scale."

The acquisition was completed on 31 July 2024, and both Elaine Murphy and Gerry McGettigan will remain within the business to ensure a smooth transition and bring their wealth of expertise to Clinigen's new Lifecycle Services division.

Contact details

Fight or Flight on behalf of Clinigen
[email protected]

Notes to Editors

About Clinigen

Clinigen is a global, specialist pharmaceutical services company focused on providing ethical access to medicines. Its mission is to accelerate access to medicines for patients in every corner of the globe. The Group supports pharmaceutical and biotech companies across the medical product lifecycle, from clinical through to commercial and operates from sites in North America, Europe, Africa and the Asia Pacific. Clinigen has more than 1,000 employees across five continents in 15 countries and provides access in more than 130 countries every year.

For more information on Clinigen, please visit http://www.clinigengroup.com.

About Kinesys

Kinesys was formed in 2007 to provide Regulatory and Product Development Strategy, Regulatory Agency submissions, Regulatory and Scientific Writing, and Medical Device services to clients around the globe. The company's highly experienced staff and senior advisors are mostly life science PhDs or MDs. Our clients are located in EU, USA, UK and other global regions. The company's services cover all types of biopharmaceutical products across most therapeutic areas, and we provide support for all types of Regulatory Applications to EMA, FDA, MHRA and other Agencies. Kinesys engages with companies at all stages of development from early preclinical through to MAA and beyond. The company has a number of specific areas of broad and deep expertise, including Haemato-Oncology, Immunology, Neurology, Ophthalmology and Rare Diseases. The Kinesys Regulatory Advisory Board includes ex-EMA / CHMP members, previously responsible for the decision-making of products filed for marketing approval at EMA, as well as ex-assessors from National Competent Authorities.

For more information on Kinesys, please visit https://kinesysconsulting.com/.

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