regulatory submissions

ADVANCED CELL & GENE THERAPY, LLC is a consulting firm specializing in the development and commercialization of cell therapy, gene therapy, and tissue-engineered products. Founded in 2002 by Scott R. Burger, MD, it provides guidance informed by over 120 years of combined experience in manufacturing, regulatory, quality, strategic, and device aspects of these products.

analytical methods development and validationAutomationclosed-system processingdue diligenceexpert witnessGMP manufacturing consultingprocess developmentquality auditsscale-up/scale-outtechnology transfer

Company / About Us / History History Putting the Spotlight on Biotech Innovation How Can We Help? SCROLL Company Origins In the spring of 2022, Allucent came into being with the merger of several high-performance companies serving the specialized needs of small and mid-size biopharma. Derived from the Latin verb alluceo, Allucent means to shine a light upon something or to create an opportunity. With a new name and bold branding, Allucent united the company and its employees under one purpose: putting the spotlight on biotech innovators and helping them deliver treatments to patients with unmet needs. OUR CORPORATE TIMELINE Partner With the A-Team Let us know how we can help you bring new therapies to light. Get in touch to get started. Schedule a Consultation Join the A-Team Want to help small and mid-size biopharma companies change the therapeutic landscape? View Open Jobs Subscribe.

AI-enabled clinical development (LucentAI)biostatistics and statistical programmingclinical development operationsclinical pharmacologydata managementGxP consultingmedical monitoringmodeling and simulationpatient recruitment and retentionpharmacovigilanceregulatory strategystudy start-up and site feasibility

Ambry Genetics is a clinical genomic testing company based in Aliso Viejo, California, and a wholly owned subsidiary of Tempus AI, Inc. For over 25 years it has provided genetic testing solutions in hereditary cancer, cardiology, neurology, and rare and exome disease, and offers pharma services supporting drug development and companion diagnostics.

assay development and validationcompanion diagnostics developmentDroplet Digital PCRexome testinggenetic testinglab automationlong-read NGSmass spectrometrymicrosatellite instability analysisReal-time PCRRNA analysisshort-read NGSSNP and chromosomal microarray

Beaufort is a MedTech-specialized contract research organization (CRO) that transforms MedTech possibilities into realities through precise, agile solutions that accelerate innovations to market. With 20+ years of MedTech experience, 1000+ global clinical trials, and 500+ global regulatory submissions, Beaufort provides clinical trial and regulatory support for medical devices, IVD, and digital health.

biostatisticsclinical monitoringclinical trial designclinical trial managementdata managementmedical writingpatient recruitmentquality assuranceregulatory strategySafety managementsite management

BioPartners is a full-service CRO and biospecimen partner for pharmaceutical, diagnostics, and medical device companies. It designs and executes biomarker studies, in vitro research, device performance evaluations, and real-world evidence programs, with integrated biospecimen collection and clinical site operations across the US (California) and Eastern Europe.

biospecimen collectionbiospecimen distributionbiospecimen processingbiospecimen storageclinical study managementlaboratory processingmonitoringpatient recruitmentProtocol developmentquality managementsite management

BioStats Statistical Consulting Ltd. is a boutique bio-statistics consulting group that combines deep knowledge of bio-statistics with industry expertise. It accompanies clients from the pre-clinical stage to regulatory submission, adding value to medical products, and offers core consulting services to bio-medical companies in all fields.

biostatistical consultingclinical data managementData Analysislectures and coursesstudy design

Boudicca® DX is a transatlantic precision medicine consulting and CRO firm with business operations legally established in the EU and US (Brentwood, Tennessee, US and Dublin, Ireland, EU). Founded by Dr. Kelly Gordon, it provides regulatory strategy and full-service CRO support for precision medicine tests, medical devices, and targeted therapies across the EU, US, and Rest of World, with 10+ years in business and 169 clients.

AI-assisted regulatory intelligenceclinical biomarker strategycompanion diagnostics developmentISO 13485IVD developmentLDT developmentQMSR complianceregulatory strategyreimbursement and market accessSaMD development

CTRG (Clinical Trials Resource Group) is a full-capacity, clinical-stage contract research organization (CRO) focused exclusively on clinical trials in the ophthalmic space. Formalized in 2019, the team has over 120 cumulative years of ophthalmology-specific clinical trial experience at the site, sponsor and CRO levels, ranging from Phase I-IV trials. CTRG provides patient safety, data integrity, and ophthalmology-specific clinical trial oversight.

clinical trial managementdata disseminationremote monitoring via electronic CTMSsafety reportingsite managementsource documentation preparation

Cloudbyz provides a unified AI-enabled eClinical trial management platform natively built on the Salesforce platform. Its products cover clinical trial management (CTMS), clinical trial financial management (CTFM), electronic trial master file (eTMF), electronic data capture (EDC), safety and pharmacovigilance, randomization and trial supply management (RTSM), patient recruitment, eConsent, and project portfolio management, along with AI agents for life sciences workflows.

AI agentsbusiness consultingclinical trial managementelectronic data capturepatient recruitmentpharmacovigilanceProfessional ServicesREST API integrationsSalesforce platform development

Confidence Pharmaceutical Research is a private, global full-service Contract Research Organization (CRO) providing tailored, end-to-end clinical trial management. It operates in the USA, Eastern and Western Europe, MENA, Latin America and APAC, with an active presence in 35+ countries and experience across diverse therapeutic areas.

clinical monitoringclinical trial managementdata management and biostatisticsfeasibility and site selectionmedical monitoringmedical writingpharmacovigilancequality assurancesite contracting and paymentstranslations

Eminence Clinical Research, Inc. is a full-service clinical trial and research consulting firm that provides clinical data management-EDC and regulatory-quality-compliance consulting services and products. It partners with corporations, physicians, and clinical trial sites to advance medical research and bring new products to market, with expertise grounded in 40+ years of experience in the medical device and hospital-based research industries.

biostatisticsclinical affairs trainingclinical trial design and managementdata managementEDC system design and buildmedical writing and scientific publicationsquality assurance