ProPharma Group (PPG), a portfolio company of Odyssey Investment Partners, announced 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 PPG’s bench of med tech experts. With expanded and dedicated expertise, PPG broadens their capabilities for developing a sound regulatory strategy framework during early research and development (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, integrated development environment (IDEs), health data exchange (HDEs), and pre-market approval (PMAs).
• Quality systems specialists help design and prepare Quality Management Systems (QMS) and standard operating procedures (SOPs) compliant with Food and Drug Administration (FDA and medical device reporting (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.”