regulatory consulting

Alpha-Omega Services, Inc. (AOS) is a US-based corporation founded in 1973 that provides radiation therapy products, services, and specialized solutions for handling and packaging radioactive materials. AOS is a contract manufacturer of sealed iridium-192 sources for HDR brachytherapy, offers NRC-certified Type B radioactive material transport casks, and provides consulting on radioactive regulations and medical device manufacturing guidance.

brachytherapy applicator manufacturingcontract manufacturingradioactive material packagingsealed source manufacturingsource installationtransport cask manufacturing

of page Putting People on Target...About Us Amergent Techs, Inc. (AT) is a disabled veteran-owned small business based in California. AT was formed in 2005 to provide maritime safety and security services and business continuity expertise to the maritime transportation and energy industries. In 2016, Amergent Techs merged with Blue Water & Associates, Inc., a small business specializing in emergency preparedness training, safety, and environmental support for terminals, pipelines, and maritime-related industries. Since 1994, Bluewater offered full-scope support to over 100 companies and facilities. Bluewater's emergency readiness support and services included contingency planning, customized emergency response tools, and practical applied training. Our collective team now provides a wide array of services to ports, energy and petroleum facilities, marine terminals and pipelines, marine.

compliance supportcontingency planningdrillsemergency planning and responsetraining

Array Environmental is a Colorado-based environmental consulting company specializing in air permitting and compliance. Founded by Claire Booth in 2017, it helps clients manage and minimize environmental risk by resolving air compliance and regulatory issues, working as an extension of client environmental teams.

air complianceair dispersion modelingair permittingcompliance auditsemission calculations

Authorized Testing Inc. (ATI) is an independent inspection and testing agency specializing in compressed-gas cylinders, pressure vessels, and related components. Since 1973, ATI has provided design qualification testing, inspection, certification, design validation, and technical support to manufacturers and regulators worldwide. ATI operates a laboratory in Riverside, California, and a remote Mojave Desert test site for destructive and hazardous testing.

bonfire testingcertificationdata acquisitiondesign qualification testingdesign validationdestructive testinghigh-speed videoinspectionmaterial and component testingon-site DOT and Transport Canada inspectionspressure vessel testingproduction inspections

Bay Group International LLC provides consulting services supporting commercial nuclear power, including independent third-party assessments and oversight, licensing, design, construction, and inspection assessments, licensing process and 10 CFR 50.55a training, and ASME Boiler and Pressure Vessel Code consulting.

ASME Code consultingconstruction consultingdesign consultingindependent third-party assessmentsinspection consultinglicensing consultingoversighttraining

Canyon Labs is a provider of testing and consulting services for the medical device and pharmaceutical markets. It offers end-to-end laboratory testing for compliance, including microbiology and sterility assurance, analytical chemistry, packaging testing, and biocompatibility and toxicology, along with consulting in regulatory, packaging, sterilization, toxicology, and analytical chemistry. Its headquarters in Bluffdale, Utah is an ISO 17025 accredited and GLP certified laboratory with Class 5, 7 and 8 clean rooms.

analytical chemistrybiocompatibility & toxicology testingclean room monitoringcold chain & thermal packaging testingEnvironmental monitoringISO 11607 packaging integrity testingISTA 7D & 7E testingmicrobiology testingpackaging testingsterility assurancesterilization consulting

Cenerva is a specialist training-driven ICT regulatory policy consultancy helping governments, regulators, operators and digital service providers worldwide address the challenges of today's digital economy. It delivers Telecommunications Regulatory Master Classes (TRMCs) in over 140 countries and provides regulatory consulting on spectrum management, number portability, cybersecurity and related policy areas. The company states it has been providing global telecommunications consulting and expert training since 1999.

cybersecurity advisorynumber portability implementationpolicy developmentregulatory trainingSpectrum management

Chapel Enterprises LLC is a professional consulting firm delivering strategic, regulatory, and operational solutions to public and private sector clients. It offers expert guidance in organizational planning, policy development, and process optimization, with services tailored to support growth, enhance efficiency, and achieve sustainable results.

organizational transformationpolicy developmentprocess optimizationProgram Managementstrategic planning

CovarsaDx is a boutique contract research organization (CRO) specializing exclusively in in vitro diagnostic (IVD) and medical device clinical research. It provides full-service clinical research including trial support, regulatory consulting, and quality assurance, helping sponsors navigate FDA pathways such as 510(k), De Novo, PMA, and EUA from study design to regulatory approval.

clinical study designclinical trial managementFDA submissionsquality assurance

CD BioSciences is a CRO focused on oncology testing, translational research and clinical diagnostics. It provides advanced pathology services, molecular diagnostic platforms and end-to-end lab solutions including central lab services, preclinical and nonclinical studies, and clinical and regulatory support to accelerate precision medicine development.

AI-assisted image analysisbiobankingcentral laboratory servicesdPCRFISHflow cytometryhistopathologyimmunohistochemistry (IHC)liquid biopsy/ctDNAMRD testingmultiplex IHC/IFNGSqPCRSanger sequencingwhole slide imaging

DCN Dx is an immunoassay CDMO and IVD CRO based in Carlsbad, CA. It provides contract development and manufacturing services, including lateral flow assay development, consumable and cassette design, custom readers, contract manufacturing, aseptic filling, and reagent lyophilization, along with clinical research services such as trial management, site development, biostatistics, data management, and regulatory consulting. Its 35,000+ sq. ft. facility is ISO 13485- and ISO 9001-compliant.

aseptic fillingbiospecimen collectionsbiostatisticsclinical trial managementconsumable and cassette designcontract manufacturingcustom reader designdata managementELISA developmentlateral flow assay developmentreagent lyophilization

Hall Arbitrations LLC is the practice of Debra J. Hall, a certified ARIAS-U.S. Arbitrator and experienced insurance and reinsurance umpire, arbitrator, and expert witness. She has held senior executive positions with reinsurance companies, trade associations, and receivership offices, and has served as an expert witness before arbitration panels, state and federal courts, Congress, and state legislatures.

Arbitrationexpert witness testimonylitigationMediation

Easy Global Training is based in Potomac, MD, USA, and is an information network in online regulatory training, quality compliance, and medical affairs for life sciences (drugs, excipients, devices, and combination products), food & food ingredients, dietary supplements, and complementary medicine. It offers live and on-demand webinars, e-learning self-paced modules, in-class training, white papers, e-books, guidelines, best practices, reports, job aids, and e-newsletters, plus regulatory/quality consulting.

clinical trial set-upCRO managemente-learningGMP mock auditsin-class traininglabeling/packaging requirementsmarketing authorizationmedical affairs consultingonline regulatory trainingquality consultingregulatory writingwebinars

Food Safety Net Services (FSNS), part of Certified Group, partners with customers to deliver scientific solutions and expertise supporting the food & beverage industry. Founded in 1994 by John and Gina Bellinger, FSNS operates 30+ ISO 17025-accredited testing laboratories across the United States, Canada, and Mexico, conducting millions of food safety tests each year.

allergen testinganalytical chemistry testingcertification and audit serviceschallenge studiescontract researchEnvironmental monitoringfood safety trainingmicrobial strain typingmicrobiology testingnutritional analysisprocess validationsshelf-life studies

Freelong Health, LLC provides compliance tools and expert advisory services for regulated digital health and medical device software development, integrating regulatory architecture with validation engineering. Its offerings cover ISO 13485 QMS, IEC 62304 lifecycle controls, ISO 14971 risk management, FDA cybersecurity compliance, and AI/ML validation strategy.

AI/ML validationautomation-driven continuous validationcybersecurity compliance reviewDHF remediationFDA submission supportQMS developmentrisk-based verification and validationtest harness engineering