RQM+ Acquires AcKnowledge Regulatory Strategies to Expand Regulatory Expertise
MONROEVILLE, PA (January 4, 2022) — RQM+ Corp. (“RQM+” or the “Company”), one of the largest international providers of regulatory, quality, and compliance consulting services for the world’s leading medical device, in-vitro diagnostics, and combination product manufacturing companies, announced that it has acquired AcKnowledge Regulatory Strategies (“AcKnowledge RS”), a San Diego-based firm specializing in regulatory affairs consulting for the medical device and IVD industries. The acquisition of this impressive team enhances the extensive RQM+ network of current and former FDA reviewers, scientists, engineers, and regulatory and quality experts, and adds additional expertise with FDA submissions. AcKnowledge RS has done significant work with novel and/or high-risk devices, focusing on pre-submissions, 510(k)s, IDEs, PMAs, De Novos, Breakthrough Designation Requests, and Safer Technology Program Requests. The acquisition augments the ability of RQM+ to support medical device and IVD companies throughout their entire product life cycle.
“RQM+ has always had the vision to become a worldwide leader in providing full-service regulatory and quality solutions to the medical device and diagnostic industries,” said the Company’s President, Maria Fagan. “Our exceptional business-balanced solutions, technical expertise, and leadership have been key to accelerating the success of life science companies and ultimately improving the lives of people across the globe. We’re excited to announce the acquisition of AcKnowledge RS, a high-caliber team of experts that specialize in regulatory affairs consulting exclusively for the medical device industry, and that found success supporting companies of all sizes to navigate the premarket submission process. Their unique depth of U.S. regulatory knowledge and strong connections within the regulatory affairs community, only enhance our ability to provide novel and innovative solutions for even the most complicated regulatory submission situations. RQM+ is honored to have the Acknowledge Regulatory Strategies team join us as we continue to improve lives…the lives of patients, our team members, and our clients.”
“We are thrilled to join the RQM+ family,” said AcKnowledge RS founder, Allison Komiyama. “RQM+ is an absolute leader in regulatory and quality service industry, and as an integrated team, we have the capacity to support clients throughout the medical device product lifecycle. I am excited to be able to offer clients — from small startups to well-established medical device manufacturers — a full range of international regulatory and quality solutions. The regulatory landscape is constantly evolving, and by combining forces, we can support clients with our collective knowledge, expert strategic and tactical service offerings, and best-in-class customer service. The healthcare sector is growing, and we are pleased to have teamed up with RQM+ to support innovation and help drive efforts to improve the lives of patients.”
More information on the integrated companies will be available in the coming months on the RQM+ website.
RQM+ is a leading medical device and diagnostics focused, regulatory and quality consulting firm. The Company delivers transformative solutions by providing an unrivaled collective expertise, fueled by passion for client success. RQM+’s experts are collaborative, laser-focused on client needs and committed to delivering high value solutions that exceed expectations. For more information, please visit www.rqmplus.com.
About Linden Capital Partners
Linden Capital Partners is a Chicago-based private equity firm focused exclusively on the healthcare industry. Founded in 2004, Linden is one of the country’s largest dedicated healthcare private equity firms. Linden’s strategy is based upon three elements: (i) healthcare specialization, (ii) integrated private equity and operating expertise, and (iii) its differentiated human capital program. Linden invests in middle market platforms in the medical products, specialty distribution, pharmaceutical, and services segments of healthcare. Since its founding, Linden has invested in over 40 healthcare companies encompassing over 200 total transactions. The firm has raised over $6 billion in limited partner commitments since inception. For more information, please visit www.lindenllc.com.