Clinigen acquires Kinesys Consulting to boost regulatory affairs expertise

Clinigen, a specialist pharmaceutical services business, has acquired 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.

Kinesys adds valuable expertise in regulatory strategy and execution for drugs and medical devices, complementing Clinigen’s existing capabilities in regulatory affairs, pharmacovigilance, medical information, clinical trial services, licensed and unlicensed distribution, managed access, and commercialisation.

The Kinesys team of experts will integrate into Clinigen’s Lifecycle Services division. Kinesys also brings a respected scientific and regulatory advisory board, comprised of seasoned industry veterans, including former regulatory agency assessors.

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 to Kinesys Consulting.

Clinigen CEO Jerome Charton says: “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 of Kinesys Consulting Elaine Murphy says: “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 of Kinesys Consulting Gerry McGettigan says: “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.”

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.

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