Regulatory

The Advanced Regenerative Manufacturing Institute (ARMI) is a member-based, nonprofit organization dedicated to advancing the bioeconomy of the United States. Its mission encompasses enhancing manufacturing, healthcare, and education and workforce development, aiming to create a scalable and effective manufacturing ecosystem for engineered cells, tissues, and organs.

At LMI, we’re reimagining the path from insight to outcome at The New Speed of Possible™. Combining a legacy of over 60 years of federal expertise with our innovation ecosystem, we minimize time to value and accelerate mission success. We energize the brightest minds with emerging technologies to inspire creative solutioning and push the boundaries of capability. LMI advances the pace of progress, enabling our customers to thrive while adapting to evolving mission needs. We are committed to investing over $1,000,000 annually in training, development, and tuition assistance for our staff, ensuring our team remains at the forefront of innovation.

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.

Danforth Advisors is a strategic and operational consulting firm dedicated to supporting life science companies. They provide a comprehensive range of services tailored to the unique needs of biotech and pharmaceutical companies, from operational finance and accounting to clinical development and regulatory affairs. Their mission is to empower clients with expert guidance and flexible solutions that advance scientific innovation and drive business success.

ERP International is a trusted provider of health and technology solutions, specializing in serving federal civilian and defense agencies. Founded in 2006, the company focuses on enhancing mission performance through innovative staffing, technology solutions, and business process management, all while maintaining a commitment to excellence and community engagement.

Deloitte is a leading global provider of audit, consulting, tax, and advisory services. The company is committed to improving public outcomes through a focus on people and developing relevant, timely, and sustainable solutions for clients. Deloitte's mission is to lead with purpose and drive positive change for people and communities, with a strong emphasis on social impact, sustainability, equity, and trust. Deloitte is also dedicated to helping the power, utilities, and renewables industry grow to become more sustainable, safe, and efficient, and is a fierce champion of industrials, inspiring optimism for the future.

The Conafay Group specializes in representing life sciences companies, universities, and other organizations in the biomedical space before the federal government and associated stakeholders. Since 2004, they have been helping clients advance their research and policy goals by leveraging federal government resources and building strong coalitions.

Booz Allen Hamilton is a leading management and technology consulting firm with over 110 years of experience. The company is dedicated to empowering people to change the world through innovative solutions in various sectors including cybersecurity, artificial intelligence, engineering, and defense. Booz Allen partners with government and commercial clients to tackle their most complex challenges, leveraging a culture of innovation and a commitment to excellence. The firm operates with core values of integrity, courage, service, ingenuity, and a commitment to diversity and inclusion.

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.

Glacier Support Services, LLC (GSS) is an 8(a) small disadvantaged business and Alaska Native Corporation (ANC) that provides a range of services including Healthcare Services, Research & Development, Public Health, Information Technology, and Facilities Support. GSS is committed to exceeding customer expectations while maintaining high standards of service and flexibility to meet the changing needs of clients.

DLH delivers improved health and national security readiness solutions for federal programs through science research and development, systems engineering and integration, and digital transformation. With over 3,200 employees, DLH is committed to solving complex problems faced by civilian and military customers, leveraging advanced technologies and methodologies to enhance health outcomes and operational readiness.

Sightline Ventures is a boutique Business-Development-as-a-Service firm dedicated to helping small businesses with innovative technology secure contracts with the Department of Defense (DOD). With a client-centric approach, the firm leverages deep acquisition experience to navigate the complexities of DOD funding, enabling clients to focus on their core technology and business development goals.

IAVI is a nonprofit scientific research organization dedicated to developing vaccines and antibodies for HIV, tuberculosis, and emerging infectious diseases. Their mission is to translate scientific discoveries into affordable, globally accessible public health solutions, aiming for a world where all people have equitable access to innovative vaccines and therapeutics.

MicroHealth, LLC is a veteran-owned small business specializing in comprehensive IT solutions for federal agencies. With a focus on healthcare IT, the company provides services such as agile project management, cybersecurity, software development, and data analytics, ensuring operational efficiency and compliance across diverse industries. MicroHealth is dedicated to enhancing healthcare delivery through innovative technology solutions, including telehealth services and electronic health records. The company also excels in health informatics support, providing tailored solutions for data management and clinical decision-making. MicroHealth is committed to fostering an inclusive workplace and actively seeks to hire veterans, recognizing their unique skills and dedication.

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.

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.