regulatory support

bring ideas to life – for a better health worldwide Radiopharmaceuticals CDMO / CMOProducts See what makes the Difference Radelumin® is indicated for the detection of prostate-specific membrane antigen (PSMA)-positive lesions with positron emission tomography (PET) in adults with prostate cancer (PCa) in the following clinical settings: • Primary staging of patients with high-risk PCa prior to primary curative therapy• Suspected PCa recurrence in patients with increasing levels of serum prostate-specific antigen (PSA) after primary curative therapy.More Radiopharmaceutical Partner from Development to Global Supply ABX is a trusted partner in radiopharmaceutical innovation, combining 30 years of experience with expertise across development, manufacturing, regulatory support and global supply. Our integrated portfolio of radiopharmaceuticals, CDMO / CMO services and products helps bring.

analytical procedure developmentglobal distributionGMP manufacturingproject managementQC method developmentradiolabelingradiopharmaceutical developmenttech transfer

Aerospace Safety Associates provides commercial aviation oversight and operational risk consulting for government agencies, military organizations, contractors, and smaller operators. The firm offers independent vendor assessments, audit readiness, regulatory support, and UAS operator evaluations, and supports NASA Commercial Aviation Services. It led development of NASA-STD-7919.1 and NASA's UAS operations standard. Associates each bring at least 30 years of aviation experience. It is a Service-Disabled Veteran-Owned Small Business.

audit readinessoversightrisk management consultingspeaking engagementsUAS operator evaluationsVendor assessmentsworkshops

Aldevron is a global manufacturer of plasmid DNA, mRNA, proteins, and enzymes for gene therapy, cell therapy, and RNA programs, offering development and manufacturing services from discovery through clinical trials to commercialization. The company provides cGMP and GMP-Source quality manufacturing, process development, and regulatory support for viral and non-viral vector therapies.

cGMP manufacturingcustom protein manufacturingfill/finishGMP-Source manufacturingin vitro transcriptionLNP encapsulationplasmid designprocess developmentQC testingRNP production

Apex Analytics provides strategic oversight, evaluation support, and research for clean energy program administrators, technology companies, utilities and commissions across the U.S. Its consultants have decades of experience in program support and evaluations, and the firm is an employee-owned company focused on quality and long-term client partnerships.

advisory servicesevaluation (impact and process)market assessment and potential analysisplanning and program designresearch and analysisstakeholder facilitation

Aptar is a global leader in drug and consumer product dosing, dispensing and protection technologies. The company provides proprietary drug delivery solutions, consumer dispensing, dosing and protection technologies, and beauty packaging and dispensing solutions for fragrance, color cosmetics, skincare and personal care. Aptar serves pharmaceutical, beauty, closures, food, beverage, home care and personal care markets.

3D printingcGMP analytical servicescontract research (CRO) servicescustomization and brand differentiationhigh-speed assemblyin-house testingmanufacturingmold buildingrapid prototypingresearch and developmentspray drying and particle engineeringtechnical support

Arcux is a project management and consulting firm with deep roots in Puerto Rico, providing comprehensive project management, consulting, and strategic business solutions across sectors including manufacturing, healthcare, education, hospitality, pharmaceuticals, commercial, residential, public buildings, and infrastructure. The firm reports over 30 years of experience and over $4 billion in completed projects.

bid managementcGMP implementationconstruction managementconsultingcontract oversight and performance monitoringdesign managementLean Six Sigma methodologiesPPP project structuring and procurement advisoryproduct registrationproject managementproject portfolio management and governance (PMO)Quality Management Systems implementationsite coordination and supervisionstakeholder engagementstrategic-planning

Avaliant is a resource and solutions provider based in Bellevue, Washington, offering engineering expertise in systems, software, network, communications and management engineering. It serves clients in space, aviation, healthcare information, training, manufacturing, software and integrated network & storage systems, and provides a LDPC Validation service (Avaliant Mercury).

communications engineeringLDPC validationmodeling and simulationnetwork and storage engineeringprogram managementsoftware engineeringspace system engineeringSystems Engineering

Bio Sensics develops wearable sensors and digital platforms for clinical trials, patient monitoring and health assessment. About us Bio Sensics was founded in 2007 by three scientists from Harvard University with a vision of transforming the healthcare industry through innovative technologies. Since its establishment, Bio Sensics has created new paradigms in using wearable sensors in healthcare and revolutionized the medical alert industry by creating technologies that are now being used by thousands of older adults.Bio Sensics solutions encompass comprehensive and validated technologies for collection of digital biomarkers and outcome assessment in healthcare. Our solutions are now empowering novel healthcare initiatives and important clinical trials in a variety of therapeutic areas. Careers Our team in collaboration with our research partners is constantly working on reshaping the.

clinical trial operationsdata analysis and scientific reportingdeep-learning analysisdigital assessmentsendpoint developmentwearable sensor development

Blue Engineering and Consulting (BLUE) is an engineering and consulting firm specializing in Liquefied Natural Gas (LNG) facility design, siting, compliance, and safety. BLUE serves the entire LNG industry, including satellite LNG facilities, small-scale LNG production, bunkering facilities, fueling facilities, and import and export projects. It is a small business formed on the Owner's Engineering model and is independent of technology providers, EPC contractors, and other vendors.

compliancefire protectionhazard analysisLNG facility designowner's engineeringsiting studies

Boulder Clinical Science is a CRO specializing in clinical trial protocol design and execution across all phases (1-4) of the drug/device development cycle. It combines academic and industry expertise with PhD-trained Clinical Scientists and Biostatisticians with a minimum of 20 years of clinical trial industry experience, plus seasoned Clinical Trial Managers and Monitors.

biostatisticsclinical trial designclinical trial executiondata managementmedical writingpre-clinical and bench design and execution

BRCR Global is a clinical research organization founded in 2009 and headquartered in Weston, FL. It connects sites, investigators, patients, and sponsors through a clinical research platform supporting Phase I to Phase IV clinical trial implementation across the Americas and Caribbean, with a site network including locations in Puerto Rico (Mayagüez, San Juan, Ponce, Yauco).

clinical operationsclinical trial implementationData OperationsGCP-compliant study executiononcology researchpatient recruitmentstudy start-up

Certified Nutra Labs is an NSF-certified dietary supplement contract manufacturer located in Sunrise, Florida. The FDA-registered facility holds three NSF certifications (NSF/ANSI 455 Grade A, NSF GMP Registration, and NSF Certified for Sport) and operates in-house HPLC and ICP-MS analytical labs. The company offers contract manufacturing, private label, formulation and R&D, lab testing, and regulatory support, backed by 20+ years of pharmaceutical-grade experience and 1,000+ formulations.

capsule manufacturingformulation developmentHPLC testingICP-MS testingpackaging and labelingpowder blendingstick pack manufacturingtablet manufacturing

Chemical and Pharmaceutical Solutions, Inc., founded in 2002, focuses on the production of Active Pharmaceutical Ingredients (APIs), their intermediates, and the services required to produce these products in a highly regulated marketplace. The company has assembled a global network to support products from early clinical trials through launch or generic status, helping establish supply lines, solve technical and regulatory problems, and prepare for commercialization.

API manufacturingCatalytic TransformationsChromatography / Simulated Moving Bedcommercialization supportContinuous ChemistryHigh Containment Purifications / Scavenging Technologies

Clordisys provides contract sterilization services using chlorine dioxide gas technology for complex medical devices, pharmaceuticals, and combination devices. The company operates an FDA-registered, ISO 13485-certified contract sterilization facility and offers services including feasibility studies, cycle development, validation per ISO 14937, regulatory support, and EO-to-CD conversion services.

chlorine dioxide gas sterilizationcontract sterilizationcycle developmentEO to CD conversionvalidation per ISO 14937

Cota Enterprises is a Kansas-based clinical research support company founded in 1995 by Rebecca Hoagland. It provides biostatistical analysis, clinical programming and data management, medical writing and regulatory support, CDISC specialization, and clinical design services to pharmaceutical, biotech, government, and research organizations, with a focus on data integrity, regulatory compliance, and scientific excellence.

Biostatistical analysisCDISC complianceClinical design servicesClinical programming (SAS)data managementmedical writing

Cummings Science and Technology provides tailor-made solutions across many industries, focusing on process excellence. It offers education management and workforce development programs in STEM, science R&D services, process improvement consulting, and regulatory support for private companies and the federal government. The company is based in Savannah, Georgia.

education program developmentprocess improvementscience R&Dworkforce development

Darrow Industries is a venture studio that creates, funds, and operates companies at the intersection of biotechnology, neurotechnology, and artificial intelligence, transforming breakthrough science into scalable businesses. Founded by Will Rosellini, it partners with scientists, engineers, and entrepreneurs to develop technologies that accelerate therapeutic innovation, enhance human performance, and strengthen bio-industrial infrastructure.

AI systems for data labeling, discovery, and trade-secret managementbiologics and cell therapyintellectual property protection and monetizationneurotechnology developmentventure developmentventure studio

Drew Marine provides a comprehensive array of chemical products and services for ships worldwide, serving bulk carriers, container ships, cruise ships, tankers, energy solutions, military/government, new builds, and recreation vessels. Its offerings include water treatment, cleaning, fuel management, refrigeration, welding, and sanitation programs, backed by field service, regulatory guidance, and a global supply network.

cleaningfield servicefuel managementglobal supply networkrefrigerant distribution, refilling, maintenance, and cylinder exchangewater treatmentwelding and cutting

Drug Discovery Alliances provides a pharmaceutical R&D platform backed by an integrated team of CMC consultants and a global network of preferred suppliers, driving programs from discovery phase to commercialization. Founded in 2001 by Deborah Minor, Ph.D., the company supports biotech and pharmaceutical companies with drug discovery, drug development, CMC consulting, and regulatory support.

analytical method developmentantibody manufacturingAPI manufacturingcatalysis screeningCMC consultingcrystallizationformulation developmentGMP auditingGMP manufacturingIND application preparationmedicinal chemistrypreclinical developmentprocess researchsolid form screening

Eagle Medical provides contract sterilization, packaging, contract manufacturing, new product introduction, and validation services for medical device manufacturers. It is ISO 13485:2016 certified and operates ISO Class 7 cleanrooms and laminar flow benches in Paso Robles, CA. The company offers sterilization via Hydrogen Peroxide Gas Plasma, E-beam, EtO, and Gamma, along with sterile barrier packaging, device assembly, and FDA regulatory support.

3D printingbonding and fasteningcleanroom assemblycontract sterilizationincoming inspectionpackaging developmentstatistical process controlsterile barrier packagingvalidation (IQ/OQ/PQ)

Envolve was created to assist individuals, private businesses, and government officials with developing solutions to environmental planning and natural resource conservation issues. We believe it is important to develop solutions that address the issues at hand but also strive to improve the social and long-term economic well-being of communities that they impact. Stakeholder involvement is crucial to achieving meaningful outcomes, therefore, Envolve puts an emphasis on energizing and encouraging engagement in the communities where we work. Justin Tassin Mr. Tassin is the founder of Envolve Ecological Consulting and Design. Justin utilizes his background as an environmental scientist and landscape designer to develop solutions that address the environmental, natural resource conservation, and planning concerns facing the communities of Louisiana while improving the natural environments.

coastal use permit supportenvironmental due diligencelandscape designmitigation banking and credit assistancenatural resource assessmentsPhase I Environmental Site Assessmentsthreatened and endangered species habitat assessmentsWaters of the United States delineations

Fast-Track Drugs and Biologics, LLC is a contract research organization (CRO) providing strategic planning, clinical trial and regulatory support services to the pharmaceutical and biotech industries for the development and licensure of vaccines and therapeutics for human diseases. It uses a critical path planning approach to move products through the regulatory process with the shortest timeline to product licensure.

BLA preparationclinical protocol writingclinical trial supportdata statistical analysiselectronic data captureenrollment and randomizationFDA meetingsGLP auditsIND preparationIRB approval assistanceNDA preparationquality assurancestrategic-planning

Fontaine & Nicoloro Consultants possess decades of experience supporting clients in developing their energy infrastructure. They provide technical and code compliance services across a project's spectrum for natural gas utilities, industrial facilities, and higher education institutions, specializing in liquefied natural gas and renewable natural gas project development and non-pipeline alternatives. Certified by the U.S. Small Business Administration as a Woman Owned Small Business (WOSB).

code complianceLNG project developmentoversight and process reviewprocess design and analysisRFP preparationrisk register preparationRNG project developmentsiting and commissioningutility infrastructure permitting

Freestone Environmental Services, Inc. is a multi-discipline environmental and water resources consulting firm headquartered in Richland, Washington. Founded by Dan Tyler and led by President Steve Airhart, the firm provides professional consulting for federal, state, municipal, and private clients, with a team of experienced scientists and engineers. It is a subsidiary of Deep Isolation, a nuclear waste disposal company.

compliancedata analysisenvironmental responsefield samplinggroundwater assessmentocean and marine ecologypermittingremediation planningsensor developmentsite characterizationsurface water and wetlands assessment