ProPharma’s new, holistic approach to MedTech solutions will catalyze client growth by promoting efficiency, speed, safety, and innovation. The company has combined and augmented their stand-alone groups, bringing together unmatched knowledge in the areas of global regulatory standards and strategy development, clinical research execution, quality management, market access, and emerging device and diagnostic technologies, positioning ProPharma MedTech clients for global commercialization success in the quickly evolving healthcare industry.
At the core of ProPharma’s capabilities is its Regulatory Strategy expertise, helping clients navigate the ever-changing and complex world of global regulatory frameworks. This includes submission strategy and management for U.S. FDA, Europe’s Notified Bodies and other international authorities, acting as the health authority liaison, providing scientific advice, and labeling development and review. ProPharma’s MedTech team will help craft a regulatory strategy to ensure efforts are focused on the right activities to support an accelerated market entry of the most competitive product, while also supporting the most efficient and effective market expansion within and across geographies.
ProPharma MedTech provides full CRO services tailored specifically to MedTech clients, including clinical strategy & study design development for early feasibility, nonsignificant risk, usability/human factors and pivotal device and diagnostic studies. ProPharma helps clients shape clinical strategies and study protocol development and manages execution of large multicenter and international trials. The group also provides biostatistical and data management consulting, market access and reimbursement support, harnessing ProPharma’s expertise in evaluating payer landscapes and local requirements – helping clients to maximize the reach and affordability of medical technology products.
Additionally, ProPharma offers extensive Quality Management and Compliance services, ranging from training on MedTech quality requirements, initial QMS establishment, gap assessments, design control support, software validation, and manufacturing transfers. The team offers auditing of both manufacturers and suppliers, as well as support during regulatory body inspection audits, and provides remediation assistance in response to audit findings, 483s and warning letters. Globally, ProPharma MedTech supports clients with import and export activities in their target markets, including economic operator requirements under MDR and IVDR, performing roles such as the AR and PRRC.
ProPharma’s Post Market Surveillance & Life Cycle Management services extend to device vigilance in the EU, a full service offering in the CER/PER space, device reporting and surveillance, and product complaints management. ProPharma MedTech supports both remediation activities when concerns are identified in the device reporting process and routine support to ensure the safety and effectiveness of medical devices throughout their lifecycle.
ProPharma’s MedTech team specializes in Devices, IVDs, Combination Products, and Companion Diagnostics covering strategies across myriad therapeutic areas and indications for use. The company also has expertise in areas critical for developing breakthrough technologies such as the evolving Laboratory Develop Test (LDT) regulatory landscape, Software as a Medical Device (SaMD), Wearables, Real-World Evidence (RWE), Digital Therapeutics (DTx), and Decentralized Studies.
“ProPharma’s new MedTech practice has extensive experience and offers scalable solutions tailored to client needs, regardless of size or geography,” says Dr. Ronald Freeze, Ph.D., Global Head of Medical Technology at ProPharma. “This holistic approach ensures that medical technology innovators receive the support they need at every stage of their product’s journey.”
For more information about ProPharma Group’s Global MedTech Practice and its suite of services, please visit https://www.propharmagroup.com/.
About ProPharma
For over 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality and compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
For more information about ProPharma, please visit: https://www.propharmagroup.com.
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.
For more information about Odyssey, please visit: https://www.odysseyinvestment.com/.
ProPharma Media Inquiries and Contacts:
Zosya Popik
Vice President, Global Marketing
ProPharma
[email protected]
Jason Wakeford
Associate Partner
Clarity for ProPharma
[email protected]
Media Contact
Jason Wakeford, Clarity for ProPharma, 424-385-4062, [email protected], https://www.propharmagroup.com/
SOURCE ProPharma
