ProPharma Group (PPG), a portfolio company of Odyssey Investment Partners, announces the acquisition of M Squared Associates (M2), an industry leading clinical, regulatory and quality consulting firm serving the medical device and diagnostic industry. Specializing in devices, biologics, and combination products for a wide range of therapeutic areas and disease spaces, M2 is a highly regarded partner to global medical technology organizations ranging from emerging start-ups to multinational device manufacturers.
This acquisition immediately boosts PPGs bench of med tech experts. With expanded and dedicated expertise, PPG broadens their capabilities for developing a sound regulatory strategy framework during early R&D phases through marketing approval, designing and managing clinical trials, as well as implementing Quality Systems, post-market device vigilance and regulatory compliance support.
M2’s team of specialists brings additional hands-on Clinical, Regulatory and Compliance experience for medical devices, combination products and diagnostics clients:
• Clinical affairs resources provide development and deployment of clinical strategies, clinical study design and a full suite of clinical research management services, including biostatistics.
• Regulatory experts provide support at early stages of product development and pre-submission meetings to formal preparation of 510(k)s, de novo petitions, IDEs, HDEs, and PMAs.
• Quality Systems specialists help design and prepare Quality Management Systems (QMS) and SOPs compliant with FDA and MDR regulations, support clients through FDA/ISO and Notified Body audits as well as assistance in resolution of compliance issues such as 483 observations and Warning Letters.
• International specialists with extensive experience in the preparation of Technical Files and Dossiers for CE marking under EU MDR and Health Canada Medical Device License applications.
“This acquisition is a pivotal move that will positively impact our combined client base to provide full end-to-end support for getting medical devices, combination products and diagnostics to market,” said Michael Stomberg, CEO of ProPharma Group. “M2’s added capabilities reinforces ProPharma Group’s leading position as the global single-source provider of services throughout the full product lifecycle for the biopharmaceutical, medical device and diagnostic industries.”
“Joining ProPharma Group’s team of subject matter experts brings an exceptional level of value to our medical device and diagnostic clients from early development strategy through post-approval,” commented M2 Associates Founder, Marie Marlow. “We look forward to working together to offer our clients an unrivaled suite of services globally.”
About ProPharma Group
ProPharma Group is the global, independent, single-source provider of regulatory, clinical and compliance services serving pharmaceutical, biotechnology, and medical device companies. Founded in 2001, ProPharma Group has more than 2500 colleagues worldwide providing solutions to complex challenges in a dynamic regulatory environment. With the mission to improve the health and safety of patients, ProPharma Group is focused on delivering the highest quality services throughout the full product lifecycle including regulatory sciences, clinical research solutions, life science consulting, pharmacovigilance, and medical information services.
About M Squared Associates (M2)
M2 is a highly regarded clinical, regulatory and quality consulting firm to US and international medical technology organizations. Specializing in devices, biologics and combination products for a wide range of therapeutic areas and disease spaces, M2 is an established partner of med tech companies ranging from start-ups to multinational device manufacturers. The company is a trusted advisor in providing clients comprehensive strategic solutions for complex regulatory challenges with getting the most ground-breaking technologies from concept to market.
About Odyssey Investment Partners
Odyssey Investment Partners, with offices in New York and Los Angeles, is a leading private equity investment firm with more than a 25-year history of partnering with skilled managers to transform middle-market companies into more efficient and diversified businesses with strong growth profiles. Odyssey makes majority-controlled investments in industries with a long-term positive outlook and favorable secular trends.