spacer
home > news > detailed info
INDUSTRY NEWS AND PRESS RELEASES

RQM+ Acquire Jordi Labs

RQM+


PITTSBURGH, Sept. 7, 2022 – RQM+, the leading MedTech service provider with the world’s largest global team of regulatory and quality experts, and portfolio company of Linden Capital Partners, today announced the acquisition of Jordi Labs. With these new capabilities, RQM+ provides comprehensive regulatory, quality, clinical and laboratory services, supporting market access throughout the entire product lifecycle for medical devices and diagnostics.

“As the only MedTech service provider rooted in almost 40 years of regulatory strategy, RQM+ is proud to now offer proprietary testing services for extractables and leachables, which gives our customers the fastest path to regulatory approvals,” said CEO Margaret Keegan. “We are relentlessly focused on being the best at every service we provide to MedTech manufacturers. Jordi’s world-leading testing services will help us maintain our uncompromising quality standards at every stage as we grow into a one-stop-shop to expedite patient access to life-improving technologies.”

Through innovative new processes, Jordi Labs provides chemical characterization and complex product deformulation as well as contaminant and failure investigations to MedTech manufacturers. Their team of Ph.D. analytical chemists uses its proprietary, multi-detector approach to ensure that all extractables are accurately characterized to comply with global materials testing regulatory requirements. Jordi’s publications based on their multi-detector approach are frequently cited by both regulators and industry.

“We are delighted to now be a part of the RQM+ solution that brings customers to market faster with our unmatched track record of rapid testing results that satisfy the stringent requirements of regulators globally,” said Mark Jordi, president of Jordi Labs. “Joining RQM+ will enable me to focus on what I love – developing groundbreaking technology that ensures patient safety by setting new standards for extractables and leachables testing.”

Kirkland and Ellis LLP served as legal advisor to Linden. Harris Williams represented Jordi Labs.

About RQM+ RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts. We provide comprehensive regulatory, quality, clinical and laboratory services, supporting market access throughout the entire product lifecycle for medical devices and diagnostics. With more former FDA, MHRA and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties. RQM+ currently works for eight of the top 10 medical device manufacturers and seven of the top 10 IVD companies. For more information, visit 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 45 healthcare companies encompassing over 250 total transactions. The firm has raised over $6.5 billion in limited partner commitments since inception. For more information, please visit www.lindenllc.com.
phone +1 877 652 0830
web https://www.rqmplus.com/
email 2790 Mosside Blvd. Monroeville, PA 15146 Suite 800 United States (U.S.)
 
Print this page
Send to a friend
   
spacer
News and Press Releases

Elligo’s Rebecca Kush, Ph.D., Elected Chair of Vulcan Advisory Council: Connecting Clinical Research and Healthcare


More info >>


White Papers

Backward Thinking: The Reverse Engineering of A Pressurized Metered Dose Inhaler

Development of a generic equivalent to a current marketed pressurized metered dose inhaler (pMDI) product brings immense challenges. Thorough analysis is critical to gain a comprehensive understanding of the physical attributes and pharmaceutical performance of the reference marketed product. Many factors need to be assessed, understood and combined in order to successfully develop a generic pMDI which will meet the regulatory and quality requirements as an equivalent product in the anticipated target market. Significant information about the reference marketed product can be obtained from a thorough review of published literature, specifically the Summary of Product Characteristics (SPC) and Patient Information Leaflet (PIL). Additionally, baselining the reference marketed product for pharmaceutical performance offers a working target specification for in-vitro correlation. It will ensure the smoothest possible path to commercialization and maximize return on investment. In addition, baselining of the reference marketed product is done to understand batch-to-batch variability and product performance over the stated shelf life to establish targets for critical quality attributes (CQAs), which can be applied to the generic equivalent pMDI.
More info >>

 
©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement