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.

The Medical Device Plug-and-Play (MD PnP) Interoperability & Cybersecurity Program, established in 2004 at Massachusetts General Hospital, is dedicated to improving patient care through the development and adoption of integrated clinical environments enabled by interoperability. The program focuses on promoting innovation in patient safety and clinical care by leading the development of smart, secure, patient-centric integrated clinical environments. It has been recognized internationally for its leadership in medical device interoperability, cybersecurity, and informatics research and innovation.

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.

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.

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.

Alira Health is a global consulting and clinical services company that aims to humanize healthcare and life sciences through innovative technologies and expert guidance. They focus on improving patient outcomes by integrating patient voices into the development of treatments and enhancing care quality across the healthcare ecosystem.

Aerstone is a cybersecurity firm dedicated to elevating businesses beyond the security status quo. With a focus on personalized cybersecurity solutions, Aerstone prioritizes understanding the unique needs and challenges of each client. The company is NSA-certified and boasts over 20 years of experience in the field, offering a boutique approach to cybersecurity that emphasizes quality over quantity. Aerstone's mission is to secure the digital world, one client at a time, by providing tailored strategies that deliver maximum impact. Aerstone's security architecture services are designed to fortify digital landscapes, safeguard assets, and keep organizations ahead of evolving threats, ensuring compliance and business continuity.

Hatch PD specializes in product design and development, offering a comprehensive range of services from concept to consumer. With a focus on innovation, efficiency, and quality, Hatch collaborates with clients to transform ideas into market-ready products while ensuring seamless integration of design and manufacturing processes. Their all-in-one approach integrates hardware, software, and firmware development, reducing time to market and enhancing product quality.

Guide Biomedical Solutions, LLC, also known as Guide-Bio, provides comprehensive tech advisory services for FDA-regulated manufacturers. The company is a proud member of key U.S. Government R&D and manufacturing consortia, offering wrap-around services from pursuit to post-market surveillance. Guide-Bio has a strong track record of helping clients secure significant non-dilutive funding and supports various biotech and life science organizations through strategic alliances and business development.

SASRAC provides trusted, authoritative research and consulting services focused on occupational and environmental safety and health challenges. With expertise in developing hearing damage risk criteria, measuring impulsive noises, evaluating hearing protector performance, and creating wireless audiometric testing technologies, SASRAC has been at the forefront of applied research since the 1970s. Founded by experienced professionals from the USAF and CDC/NIOSH, SASRAC is dedicated to advancing technologies in audiology, bioacoustics, and hearing conservation.

Southwest Research Institute (SwRI) is a nonprofit research and development organization that provides independent, premier services to government and industry clients. Founded in 1947, SwRI is committed to advancing science and technology to benefit humanity, focusing on innovative solutions that improve human health and safety. With a diverse range of technical divisions, SwRI addresses complex challenges in various fields including mechanical engineering, materials, aerospace, automotive, biomedical, and more.

Phlow Corporation is a U.S.-based public benefit pharmaceutical manufacturing company dedicated to revolutionizing the production of essential medicines. By leveraging advanced manufacturing processes, Phlow aims to ensure the availability of high-quality, affordable pharmaceuticals and active pharmaceutical ingredients (APIs) domestically. The company is committed to reshoring pharmaceutical manufacturing to the United States, thereby enhancing the nation's healthcare security and reducing dependency on foreign supply chains. Phlow's mission is to provide every American with access to essential medicines, supporting public health and national security. The company also emphasizes sustainability and community engagement, integrating green chemistry and continuous manufacturing to reduce environmental impact and improve the sustainability of pharmaceutical production.

BioBridge Global is a nonprofit organization dedicated to saving and enhancing lives through the healing power of human cells and tissue. It operates a family of nonprofits including South Texas Blood & Tissue, QualTex Laboratories, GenCure, and The Blood & Tissue Center Foundation. The organization provides lifesaving therapies to patients and supports advances in advanced therapies, focusing on blood, cell, and tissue products, testing services, and the development of new therapies.

Viscus Biologics LLC specializes in product realization from ideation to high volume production, manufacturing components, devices, and products with natural polymer and extracellular matrix materials. The company aims to fulfill patient and market needs, improve quality of life, and restore tissue to a healthy state.

Leidos is a leading systems integrator in science, technology, and engineering, dedicated to solving some of the world's toughest challenges. The company emphasizes a commitment to integrity, diversity, and sustainability while delivering innovative solutions across various sectors including defense, healthcare, and energy.

MassBiologics, part of UMass Chan Medical School, is the only nonprofit, FDA-licensed manufacturer of vaccines and biologics in the United States. With over 100 years of experience, it is dedicated to improving public health through the research, development, and production of biologic products, including vaccines and monoclonal antibodies.

TDA Research, Inc. is dedicated to addressing complex real-world problems through innovative research and development in chemical processes, materials, and hardware. With a focus on agility and collaboration, TDA partners with clients in defense, aerospace, energy, and chemical industries to deliver cutting-edge solutions and technologies.

Orgenesis Inc. is dedicated to unlocking the potential of cell and gene therapies (CGTs) by providing affordable and accessible solutions. The company focuses on overcoming the challenges of processing personalized CGTs locally to impact patients globally. Through its POCare Platform, Orgenesis aims to lower costs and standardize high-quality CGTs, making advanced therapies more accessible to patients worldwide.

BioTechnique® is a full-service Contract Research Development and Manufacturing Organization (CRDMO) specializing in sterile injectable fill-finish services. With a commitment to quality and innovation, BioTechnique® aims to enhance healthcare outcomes worldwide by providing high-quality life-saving products and maintaining the highest standards in pharmaceutical manufacturing.

MRIGlobal is a renowned Midwest research institute based in Kansas City, dedicated to improving the overall health, safety, and well-being of people everywhere. With over 80 years of experience, MRIGlobal specializes in diagnostics, pharmaceutical sciences, vaccines and therapeutics, global health surveillance, infectious disease, public health, warfighter protection, agriculture, and management and operations. The organization is committed to using science and technology to create solutions for a safer, healthier, and more sustainable world.

Creare is a leading innovator in technology and product development, specializing in engineering research and development services. With over 50 years of experience, Creare combines sophisticated analytical methods with creative engineering to solve complex challenges across various sectors, including biomedical systems, cryogenics, fluid dynamics, and advanced manufacturing. The company is dedicated to delivering innovative solutions that enhance product functionality, reduce costs, and accelerate time-to-market for its clients. Technology commercialization has been a key part of Creare’s mission since its founding in 1961, leading to significant revenue generation through licensing and spin-offs.

RegenMed Development Organization (ReMDO) is a 501(c)3 non-profit organization dedicated to accelerating the discovery and translation of regenerative medicine therapies. By conducting research to de-risk technologies and promoting biomanufacturing scale-up and automation, ReMDO aims to make regenerative medicine technologies more affordable and expedite their transition to clinical practice. The organization collaborates with thought leaders, research centers, and companies to advance the field and improve patient outcomes.

Emergent BioSolutions is dedicated to developing, manufacturing, and delivering medical countermeasures that address public health threats. With a mission to protect and enhance life, the company focuses on innovative vaccines and therapeutics to combat critical health challenges, including the ongoing opioid crisis.

RQMIS (Regulatory/Quality Management Information Source) is a global regulatory consultancy dedicated to guiding medical device, pharmaceutical, nutraceutical, and cosmetic companies through the complex pathways of product development, regulatory approval, and market sustainability. Established in 1996, RQMIS operates from strategic locations in Amesbury, Massachusetts (USA); Barcelona, Spain; and London, United Kingdom, enabling comprehensive support for clients worldwide. RQMIS emphasizes personalized service, ensuring accessibility and responsiveness to client needs. The firm's mission is straightforward: to bring clients' products to market efficiently and maintain their success through ongoing compliance and strategic support.

Fort Defiance Industries (FDI) is an FDA-registered, ISO 13485-certified medical device engineering and manufacturing company based in Loudon, TN. Established in 2006, FDI specializes in providing innovative medical devices and technical services to military and commercial markets, focusing on enhancing medical capabilities in austere environments.

DesignPlex Biomedical specializes in the prototyping, design development, and contract manufacturing of medical devices. The company is dedicated to improving patient outcomes through innovative medical solutions, focusing on quality and collaboration with clients to bring their ideas to life.

VitaCyte specializes in the manufacture and supply of GMP Grade purified-defined collagenase and protease enzymes for cell and tissue dissociation. The company is dedicated to supporting researchers, commercial cell suppliers, and institutions involved in cell therapy and transplantation, providing high-quality products that enhance the efficiency and effectiveness of cell isolation processes. VitaCyte is committed to improving the science of cell recovery and has a history of innovative solutions in the field of cell isolation, contributing to significant advancements such as the Edmonton Protocol for islet transplantation. Their products, particularly the purified-defined collagenase, ensure high lot-to-lot consistency and rigorous enzyme characterization, setting a standard in the industry.

Tunnell Government Services, Inc. is a subsidiary of Tunnell Consulting, Inc., dedicated to providing professional services to government agencies. The company focuses on transforming organizations to achieve sustainable results and fulfill agency missions. With expertise in public health preparedness, biodefense lab support, and scientific project portfolio management, Tunnell Government Services partners with government organizations to address the greatest threats to public health and enhance organizational performance.

The University of Ottawa is a leading research university in Canada, known for its commitment to academic excellence, diversity, and innovation. It offers a wide range of undergraduate and graduate programs, fostering a vibrant community for students, faculty, and alumni. The university emphasizes a bilingual education and provides numerous opportunities for students to engage in research and community service.

nou Systems is dedicated to transforming defense systems through innovative, mission-driven technology. With expertise in systems engineering, modeling and simulation, and real-time open systems development, the company delivers powerful, data-driven insights that enhance system capabilities across various complex defense systems.

Innovative Design Labs (IDL) is a research and development company based in Minneapolis, Minnesota, founded in 2010. The company focuses on creating affordable and effective products to improve lives, specializing in developing technology from concept to manufacturing for medical, consumer, and education markets. IDL collaborates with leading hospitals, rehabilitation centers, academic institutions, and industry partners to bring innovative solutions to market. Their expertise spans embedded electronic systems, wireless communications, sensor fusion, algorithm design, computer vision, and more.

MDD Options, LLC offers a hybrid sales model for MedTech companies, combining the strengths of a distributor with those of a third-party logistics provider. This approach accelerates revenue streams for manufacturers by maintaining direct customer contact while managing business processes that facilitate sales transactions. The company supports both domestic and foreign manufacturers, providing services such as US Agent and Initial Importer roles, state registration, sales tax management, and supplier credentialing. MDD Options also offers a range of flexible options and services to help MedTech companies navigate the complexities of market entry and sales.

TechWerks is a service-disabled veteran-owned small business (SDVOSB) that provides innovative solutions for federal and commercial health IT communities. With a focus on healthcare, information technology, and research, TechWerks leverages its domain expertise to deliver high-quality services in technology solutions, business solutions, research and evaluation, resilience and behavioral health, and training and workforce development.

Medtrade is a global medical device company based in the UK, dedicated to saving and improving lives through innovative solutions in wound care, trauma, and hemostasis. With a focus on tackling global health challenges, Medtrade provides advanced manufacturing, regulatory, and marketing support to distribution partners worldwide.

Athena GTX is dedicated to advancing wireless, mobile, patient-worn monitoring solutions for both military and civilian markets. The company focuses on connecting patients and providers through state-of-the-art medical and communication technology, developed and produced in Iowa. Athena GTX aims to enhance patient outcomes by integrating innovative wireless technology with reliable devices, supporting first responders and medical professionals in various challenging environments.

Matregenix is a global leader in nanofiber technology, specializing in highly customizable nanofibrous materials for diverse applications, particularly in filtration and biomedical fields. The company is committed to pushing the boundaries of nanofiber technology through innovative platforms and state-of-the-art electrospinning machines, providing comprehensive contract development and manufacturing services to help manufacturers bring their innovations to market.

Octapharma USA is a leading healthcare company dedicated to providing innovative health solutions that advance human life. As the largest privately owned plasma fractionator globally, Octapharma develops and manufactures high-quality human proteins sourced from human plasma and cell lines, focusing on hematology, immunotherapy, and critical care. The company is committed to patient engagement and community support, ensuring that their products meet the highest safety and quality standards.

International Fabric Machines appears to be in the process of establishing its online presence, as the domain is not yet connected to a website. The company may be involved in the fabric machinery industry, but specific details about its mission and vision are not available at this time.

Proxima Clinical Research, Inc. (Proxima CRO) is a leading Contract Research Organization (CRO) that specializes in providing innovative solutions for medical devices, drugs, and diagnostics. With a focus on agility and efficiency, Proxima aims to de-risk biotech and MedTech programs, enhance regulatory clearance chances, and optimize capital efficiency. The company is dedicated to supporting clients through every stage of clinical development, ensuring timely and cost-effective results.

DexTech is a U.S.-based small business specializing in advanced technologies for governmental and commercial sectors, including the U.S. Defense Department. Founded in 2020, the company focuses on delivering innovative solutions in energy production, sustainability, IT security, IoT, and health and biotech, ensuring compliance with governance and regulatory standards while enhancing operational efficiency and sustainability.

Rafa is a leading pharmaceutical company in Israel, founded in 1937, specializing in the manufacturing, marketing, and distribution of prescription and over-the-counter medicines. The company is committed to providing high therapeutic value products and has a strong focus on partnerships and innovation in the healthcare sector.