Good Manufacturing Practices

SIMETRI is a woman-and-minority owned small business based in Winter Park, Florida, specializing in modeling, simulation, and training technologies. Founded in 2009, the company focuses on delivering innovative products and services that enhance the human experience and improve client outcomes through advanced training and program management analysis.

Nanohmics Inc. is a Texas-based research and development company founded in 2002, specializing in the applied sciences of light, molecule, and advanced material interactions. The company focuses on designing and developing smart technology solutions that enhance product, technology, or system performance across various industries. With a multidisciplinary team of scientists and engineers, Nanohmics integrates advanced materials and state-of-the-art instrumentation engineering to create custom-engineered sensing technologies and platforms. Their mission is to accelerate client success through innovative product development, providing solutions for detection, surveillance, electro-optic imaging, performance characterization, environment awareness, and energy conversion applications.

Omnica Corporation is dedicated to advancing the medical device industry through innovative design and engineering solutions. With nearly four decades of experience, the company specializes in rapid medical device development, providing comprehensive services that include prototyping, verification, and validation. Omnica's commitment to quality and customer satisfaction is reflected in its high rate of repeat business and long-term client relationships.

Tanner Research, Inc., founded in 1988, specializes in advanced electronics, micro-electro-mechanical systems (MEMS), mechanical designs, software, and autonomous robots. The company is committed to innovation and technology, aiming to solve challenging problems for clients in government, industry, and academia. With a focus on R&D, Tanner Research pushes the limits of technology to deliver unprecedented capabilities in various domains.

Advanced BioScience Laboratories, Inc. (ABL) is a global biomedical contract research and manufacturing organization dedicated to advancing vaccines, therapeutics, and other biologic products. ABL leverages its expertise in product development, GMP manufacturing, and immunological testing to support the development of candidate vaccines and therapeutics through preclinical and clinical stages. The company is involved in producing and testing oncolytic viruses, gene therapies, immunotherapies, viral vaccines, and recombinant protein vaccines.

Clinical Research Strategies (CRS) is a Pittsburgh-based contract research organization and executive management consultancy dedicated to improving the performance of start-up and mid-size life sciences companies. With a focus on instilling fiscal discipline and reducing risks in clinical development, corporate affairs, and quality assurance programs, CRS provides tailored consulting and staffing solutions to navigate the complexities of regulatory pathways and ensure successful product launches. CRS is also committed to leveraging advancements in artificial intelligence and machine learning to enhance clinical research and regulatory processes.

Ease Healthcare (a registered DBA of MPS Medical, Inc.) is committed to advancing next-generation military medicine by accelerating access to clinically validated diagnostic tools, monitoring devices, and health and wellness technologies. As a trusted commercialization partner and distributor, the company empowers providers, organizations, and individuals with advanced solutions that support early detection, timely intervention, and improved health outcomes in both civilian and military settings. With a mission to make cutting-edge science and technology accessible to all, Ease Healthcare focuses on addressing critical health challenges such as 02 delivery, cancer, and cardiovascular disease —areas that directly impact force readiness and resilience. The company’s vision is to break barriers in healthcare by delivering innovative medical solutions that are affordable, accessible, and simple to use, regardless of economic or geographic limitations. In addition to bringing transformative technologies to market, Ease Healthcare provides turnkey services for medical device manufacturing and distribution, guiding partners from product development through regulatory compliance and successful deployment. By combining technical expertise with a dedication to accessibility, Ease Healthcare supports the Department of Defense’s priorities in preparing and protecting service members with next-generation healthcare solutions.

EmergingDx is dedicated to inventing, developing, and commercializing emerging technologies and products aimed at improving the quality of the human condition while positively impacting the environment and society. The company comprises a diverse team of world-class scientists, engineers, product designers, and business leaders with a proven track record of innovation and successful technology transition.

PPD, a clinical research business of Thermo Fisher Scientific, is a leading provider of global contract research organization (CRO) solutions. The company is dedicated to helping clients accelerate the development of life-changing therapies through comprehensive drug development, laboratory, and lifecycle services. With a commitment to operational excellence and innovative technology, PPD empowers its customers to bring therapies to market faster and improve patient health. PPD has been recognized as an industry leader in clinical development digital transformation services and patient engagement digital transformation. With over 30 years of clinical leadership and a workforce of more than 30,000 employees globally, PPD has conducted over 2,100 trials in the past five years.

Simbex is a leading partner in medical device and consumer health product design and development, recognized for transforming complex ideas into commercially successful solutions. With a multidisciplinary team, Simbex excels in engineering, product design, software, data analytics, and commercialization strategy, supporting innovators from concept to market. Their mission is to deliver impactful medical devices and consumer health products that improve health outcomes and quality of life. Simbex is known for its holistic approach, deep regulatory expertise, and commitment to innovation and excellence in the health technology sector. The company is also active in thought leadership, regularly publishing regulatory and reimbursement updates, and hosting educational webinars for the MedTech community. Simbex maintains a robust Quality Management System compliant with ISO 13485 and FDA 21 CFR 820, ensuring high standards in product development. The company is also committed to supporting diversity in MedTech, including initiatives for women in the sector. Simbex's leadership and advisory team bring decades of experience in biomedical engineering, commercialization, regulatory affairs, and technology innovation, further strengthening its position as a trusted partner in the MedTech ecosystem.

RoosterBio, Inc. specializes in simplifying the use of adult human mesenchymal stem/stromal cells (hMSCs) to accelerate the commercialization of therapeutic technologies. The company provides high-quality, scalable solutions for cell therapy, gene therapy, exosomes, tissue engineering, and bioprocessing, enabling researchers and developers to bring innovative therapies to market more efficiently. RoosterBio is committed to making living cells more affordable and accessible, driving the transition of hMSCs from a scarce resource into an abundant one. Established in 2013, RoosterBio aims to fuel the rapid implementation of scalable advanced therapies, ensuring that safe and effective treatments are widely available globally.

PSC Biotech is a leading life science consulting firm that specializes in providing comprehensive solutions to highly regulated industries. With over 25 years of experience, PSC Biotech focuses on ensuring compliance, enhancing operational efficiency, and delivering high-quality consulting services tailored to the unique needs of clients in the pharmaceutical, biotechnology, and medical device sectors. The company operates in 52 countries globally and has served thousands of clients, employing a global team of skilled professionals and experts. PSC Biotech is committed to elevating quality management systems and ensuring data integrity through innovative solutions and partnerships.

Solventum is a healthcare company dedicated to enabling better, smarter, and safer healthcare solutions. With a legacy of innovation, Solventum focuses on improving patient outcomes through advanced medical technologies, oral care solutions, health information technology, and purification and filtration systems.

JAKTOOL is a premier product development, engineering, and precision prototyping company based in Cranbury, NJ. With over 25 years of experience, JAKTOOL specializes in delivering high-quality turnkey engineering solutions for heavily regulated industries, including medical technologies, military, and aerospace. The company is committed to innovation, quality, and customer satisfaction, providing a collaborative environment that fosters personal and professional growth.

Smith+Nephew is a portfolio medical technology company focused on the repair, regeneration, and replacement of soft and hard tissue. The company aims to restore people's bodies and their self-belief by using technology to take the limits off living. With a commitment to medical education and improving patient outcomes, Smith+Nephew operates in over 100 countries and is dedicated to sustainability and community health. Their purpose is to promote health and wellbeing, not just through their products but also by ensuring a positive impact on society and the environment. Smith+Nephew is also committed to increasing diversity within the medical device industry through initiatives like the Orthopaedics for All global advisory board.

Terumo Blood and Cell Technologies is a global leader in medical technology, specializing in blood and cell-based therapies. With over 7,900 team members, the company is dedicated to advancing healthcare by providing innovative solutions for blood collection, processing, and storage. Their mission is to empower healthcare providers with the tools and insights needed to deliver high-quality care to patients worldwide. Terumo BCT is committed to unlocking the potential of blood and cells, offering a range of products and services that support lifesaving transfusions and next-generation therapies for diseases like cancer. The company is part of the Terumo Group, which has been contributing to society through healthcare for over a century.