Certified Women-Owned Research and Development in Biotechnology (except Nanobiotechnology) in Maryland

EMPIVE is a veteran, black woman-owned company, providing goods and services to medical, and biotech industry through scientific, clinical, information technology and engineering services.

IntelliGenesis LLC delivers mission-focused innovation to the Department of War and Intelligence Community (IC) through Cyber Operations (DCO/OCO), AI/ML, Generative AI, Agentic AI, Analytics, All-Source Intelligence, and Technical Training services, solutions, and technologies With over 19 years of experience, IntelliGenesis operates an 8,000 sq. ft. on-prem h/w for rapid AI prototyping and cyber-physical capabilities. Headquartered in Columbia, MD, with offices in Augusta, GA, and San Antonio, TX, and personnel in HI, CO, and UT, we hold Prime Contracts across multiple agencies. In addition to our services, our product suite includes CYBERSPAN® (cyber defense and DIB protection), KrakenAI™ (adaptive AI/ML data fusion), and DryDock™ (agentic AI). Through IntelliCademy™, we deliver AI and Cyber training aligned to DoD 8140 and ISO/IEC 17024, enabling mission success through people, technology, and innovation.

Kandih provides comprehensive professional support services centered on toxicology and regulatory compliance. Our team of expert regulatory toxicologists and clinical specialists meticulously oversee nonclinical and clinical studies conducted at Contract Research Organizations (CROs) to ensure strict adherence to Good Experimental Practice (GxP) guidelines. We excel in conducting in-depth regulatory intelligence, gap analysis, and due diligence assessments for clients undergoing mergers and acquisitions. Our combined expertise in toxicology and regulatory affairs empowers us to deliver precise environmental risk assessments, calculate permissible exposure limits, and conduct thorough literature reviews to substantiate weight of evidence for carcinogenicity studies. Kandih is adept at crafting compelling regulatory submission documents and navigating the complex landscape of global regulatory interactions.

Regulatory writing (pharmaceutical/medical device) in all therapeutic areas (hematology/oncology, reproductive medicine, bone health, orthopedics, dermatology, cardiovascular, neurovascular, urology, infectious disease, rare disease, cancer Immunotherapeutics, vaccines, pharmacogenetics •Manuscripts/reports, regulatory submissions, patient education materials, SOP, consent, protocol, case reports, summary of clinical efficacy/safety, clinical study report, aggregate reports (integrated summary of safety, development safety update report, periodic safety update report, periodic benefit-risk evaluation report, periodic adverse drug experience report), individual safety reports, risk management plan •Supporting medical component of pharmacovigilance/drug safety activities Developing educational materials/CMEs for health care professionals and patients (webinars, Classroom, e-learning training, e-books) using Criterion-Referenced Instruction (CRI) instructional design

Gant Global Services (GGS), Inc. is a consulting firm established in 2011 and is owned and operated by two veterans with 16 employees. GGS provides project/program management and administrative support services by a multi-disciplinary team of subject matter experts in strategic, operational, and technological management. We seamlessly augment organizations with the right people, skills, and technologies timely and effeciently for healthcare, EEO, IT and Cyber Security.

Our projects include the development of biological therapeutics for human cancer and viral infections. We have created vaccines for COVID-19, influenza, and HCV. Additionally, our product line includes primary cell isolation, tissue culture systems, stable cell line & IPS cell . DNA synthesis & cloning, In vitro & in vivo gene transfer. Nonviral vector & minicircle DNA technology for long term and high-efficient episomal protein expression.

Delivers health strategy, management, and policy consulting. Provides planning; evaluation & analysis; technical assistance. Focused on veterans’ and military health, neuroscience and mental health, public health, IT, scientific services & education.

Solutions and services in Health, IT and Engineering including health and biomedical research, systems modernization, staffing, data solutions and administrative services.

KamTek, Inc. is a Women-Owned Small Business (WOSB) providing cGMP-compliant biorepository storage, biospecimen management, and laboratory support services. Located in Frederick, Maryland, KamTek supports federal agencies, biopharmaceutical companies, and research institutions with secure storage at ambient, 4°C, -20°C, -80°C, and liquid nitrogen (-196°C). Services include sample processing (aliquoting, PBMC isolation, nucleic acid extraction), ICH stability storage and testing, custom kitting, cold chain logistics, and nationwide distribution. The facility is ISO 9001:2015 certified, FDA-registered for blood storage, and compliant with 21 CFR Part 11 and 21 CFR Part 211, with redundant monitoring, backup power, and 24/7 environmental control.

• Pre-clinical Development • Phase I-IV Trial Support • Regulatory Affairs • Investigational New Drug (IND) Preparation & Filings • 510(k) • Trial Design • Biostatistics • Medical Writing & Communications • Site Monitoring • Compliance Audits • FDA Readiness Audit • Risk Management • Patient-focused Recruitment • SOP Development & Implementation • Risk Evaluation and Mitigation Strategy (REMS) • Pharmacovigilance • Site Management • eCTD Dossiers & Publication • Computer-aided Drug Design (CADD) • Pharmacokinetics & Pharmacodynamics (PK/PD) • Drug Metabolism and Pharmacokinetics (DMPK)

GSSHealth provides management consulting and technical assistance to international public health programs. Areas of expertise: Business & Strategic Planning Communications Quality Assurance & Safety Supply Chain Management Procurement Training

Develop and execute customized training programs in management, leadership, project management, customer service, FDA compliance, software, healthcare, GMP, & life sciences/bioscience industries. Services also include curriculum development to support university and college courses; meeting facilitation, retreats, scientific writing, technical writing, risk management, database administration, project management, scheduling, PMP

Significance provides a range of support services, from Program Management, Financial Improvement, PPBE Expertise,Strategic Communication Support,Workforce Planning,the best of breed tools and innovation to meet goals of organization.

MPF Federal provides a variety of services dedicated to offering cost effective and efficient solutions to government requirements.

Requirement Management End-to-end Application and Product Development System Engineering and Integration Project and Program Managment QA/Testing/Configuration and Release Management

Subject matter experts in the area of pharmaceutical, bio-pharmaceutical, medical in devices and compounding laboratories operations. Specializing in operation management and quality systems for active pharmaceutical ingredients, finished pharmaceutical, medical devices and biological products. Specializing all aspects of manufacturing, validation, microbiology, and quality assurance in GXP environments. Supporting electronic systems and risk based assessments to support regulatory compliance. Services offered include: Regulatory/Quality, Business Management and Strategic Operations, and Education and Training.

DSFederal provides IT services, data analytics, and training to clients throughout the Departments of Health and Human Services, Defense, Transportation, Homeland Security, and Agriculture. We excel at providing best value solutions that help agencies manage and disseminate critical information, from groundbreaking biomedical research to emergency response to curriculum.

ZemiTek is a 8(a), woman-owned, small disadvantaged business providing institutional/technical support, IT and international development services to U.S. federal agencies since 2007. Through several contracts, ZemiTek has provided U.S. agencies with experts in economic analysis, research/strategic planning, policy, agriculture, private sector engagement, engineering, management, HR/workforce planning, training, communications, knowledge management, IT (websites, mobile, and cloud solutions), facilities, operations and administrative support, project management, business analysis, software development, training and deployment and operational support. ZemiTek staff has traveled and provided services internationally to over 60 countries. ZemiTek holds a Secret Facility Clearance as well as GSA IT 70 and PSS Contract Vehicles. Past clients include: USAID, GSA, USDOJ, USDA, DHS, NARA, USPTO.

FCN is a premier provider of Commercial off-the-shelf (COTS) Information Technology products for the DoD and Federal agencies. FCN provides networking, storage, enterprise HW/SW solutions and services, vital to the operations of the Federal Government.

We specialize in: Health IT, Healthcare Quality, GIS, BI, Informatics, MDM, Data Warehouse, Program Management, Project Management, Predictive Modeling, PMO Consulting, Change Management, Peoplesoft, Informatica, Business Objects, Engineering Services, CAD, CAE, Quality Assurance, Mission Assurance, Space Sciences, Earth Sciences, Software Engineering, Databases, Oracle

Ripple Effect provides professional consulting and exceptional staff augmentation for federal, private, and non-profit clients to deliver some of the most crucial policies and programs that shape our nation. Our core capabilities include research and evaluation; communications and outreach; program management and policy; digital transformation; and technical & scientific services.

Inomal Healthcare Concepts, LLC, is an innovative cutting edge and quality driven, Healthcare Information Technology and Process Improvement company headquartered in Annapolis Maryland. We are a Woman and Minority owned Small Disadvantaged Business (SDB) business. Inomal Healthcare strategically aligns with organizations to seek a path forward to sustain a roadmap of excellence and efficiency. Providing, key staff and team members that can operate effectively within the clinical healthcare and technology arenas, saving our customers time and money. Focusing endlessly to help organizations to improve their clinical, technical, scientific, and business processes and bottom line. Inomal Healthcare is committed to flexible solutions for the government and commercial clients.

AOTEK, LLC supports Government and private professional consulting and logistics consulting services; administrative, translations and interpreting services and much more.

Garud offers proven solutions and expertise in computer Programming, Engineering solutions, Integrated Security Solutions, Logistics Services & Support; Lighter than air UAV, and Information Technology Services.

Rose Li and Associates, Inc. (RLA) is a woman- and minority-owned small business professional services company that uses its multidisciplinary expertise to provide professional science writing services in a variety of content areas; prepare state-of-the-science assessments that often signal where future research investments should be made; help clients plan and staff scientific meetings; and manage committees, projects, and scientific reviews. Since our inception in July 2003, RLA has provided professional services support to the National Institutes of Health (NIH), other Federal agencies, and private and non-profit entities. A listing of current and past clients can be found at www.RoseLiAssociates.com. RLA is reputed for its high-quality work, and is adept at matching the appropriate expertise needed for the task at hand, conducting cost-conscious management of contracts, and meeting demanding time lines.

Data Management Monitoring Audit Coordination