regulatory strategy

Affirmed Pharma is a translational drug development company whose teams coordinate investigational, regulatory, intellectual property and commercialization strategies to move promising development-stage drugs through regulatory approval with new patents. It targets therapies in late-stage pre-clinical or early clinical development at research organizations, universities and university spin-out companies lacking commercialization experience, leveraging patent family development strategies with formulation and clinical research organizations.

clinical researchcommercialization strategyformulationintellectual property strategypatent family development

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 submissionsstudy start-up and site feasibility

Anziva Pharmaceuticals Inc. is a formulation-driven drug development company focused on improving how known therapeutic agents are delivered, combining pharmaceutical formulation science, product design, and regulatory strategy. It is initially focused on non-opioid pain products, with its lead program J'Neura™, a flexible, waterproof, non-opioid transdermal patch designed specifically for the knee. The company is led by founder and CEO Dr. Simerdeep Singh Gupta.

drug delivery sciencepharmaceutical formulation scienceproduct designreformulation of known moleculestransdermal and topical delivery systems

AOTEK LLC is a provider of innovative solutions for the federal government and the private sector in the areas of health, science, and technology. It is a trusted partner of federal prime contractors and provides integrated health mission systems and information services support to the Department of Defense (DoD) and Defense Health Agency (DHA). AOTEK LLC is an SBA-certified Women Owned Small Business (WOSB) and Economically Disadvantaged Women Owned Small Business. AOTEK stands for Alpha and Omega Technologies.

Acquisition Support ServicesBiostatistics and Data ManagementcGMP/GCP/GLP TrainingClinical Trials Monitoring Supportcommunications and public relationsFDA meetingsfeasibility studiesFinancial/Budget AssistanceMedical Writing and Documentationperformance metrics and evaluationpolicy developmentProject Management IAW PMBOKquality assurance/quality controlRegulatory AffairsResearch Protocol Designrisk managementstakeholder engagementstrategic-planningtelehealth solutions

Archimedic is a medical device design firm with integrated regulatory and go-to-market capabilities. Its team of researchers, strategists, designers, and engineers helps innovators create life-changing medical devices and successful MedTech ventures, using an integrated Design + Regulatory + Go-to-Market (DRG) model to move products from concept to market adoption.

FDA interaction preparationgo-to-market planningmedical device designproduct development

Arizona Lobbying is a Phoenix-based lobbying firm providing government relations and advocacy services throughout Arizona. It specializes in state and local government affairs encompassing the legislature, cities, counties, and towns, and has over 25 years of experience in government relations. The firm is led by Principal Trish Hart and serves clients ranging from Fortune 500 companies to local businesses and trade associations.

crisis communicationsgovernment and media relationsgrassroots organizinglegislative lobbyinglegislative tracking

Asher Orion Group provides consulting services for healthcare organizations and AI vendors, helping them determine the right medical AI strategy and optimize execution to deliver clinical value. The company assists AI vendors in focusing on the right solution and reaching the right markets and customers faster, with expertise spanning technology, product management, regulatory, and market strategy across the healthcare ecosystem.

AI value quantificationalgorithm lifecycle managementclinical validationcommercial AI assessmentevidence creationmedical AI strategy consultingproduct managementtechnology roadmap planningtechnology scouting

Avinora partners with mission-driven teams to advance health and biodefense innovations, helping vaccine, therapeutic, diagnostic, and device concepts move from concept to impact. It provides expertise in product development, regulatory and clinical strategy, biosecurity, funding access, and strategic communications.

biosecurity advisorybrand and visual identity alignmentclinical strategyfunding positioningproduct development accelerationstrategic communications

Axella Research is a full-service clinical research organization for emerging biopharma, device and diagnostic companies. It combines FDA regulatory strategy, biostatistics, a community-based physician network and technology-integrated trial operations, with deep experience in oncology and urology. The company offers fee-for-service or shared-risk partnerships, and its operations run on Ecosera, an open clinical research platform.

biostatisticsclinical operationsdata managementfeasibility assessmentIND preparation and submissionmedical writingmonitoringpre-IND meetingsproject managementsite start-upSMO servicesstatistical programming

BeanStock Ventures is a San Diego-based regulatory consulting firm for medical devices and digital health, founded by engineers-turned-regulatory experts with over 25 years of medical device development experience. It provides regulatory strategy, QMS and technical documentation support, FDA submission support, and post-market support, and is an FDA-accredited Third Party Review Organization for 510(k) reviews.

CAPA managementcybersecurity risk managementDe Novo submissionsDesign History File developmentEU MDR/IVDR technical documentationFDA 510(k) submissionsFDA-accredited third party 510(k) reviewPMA submissionspost-market surveillanceQMS implementationtechnical documentation audits

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 submissionssafety managementsite management

Biologics Consulting is an FDA regulatory affairs and product development consulting firm founded in 1993 by former FDA officers as a fully employee-owned (ESOP) company. It provides integrated multidisciplinary regulatory strategy and operations support for biologics, pharmaceuticals, medical devices, and combination products, with 30+ years of history, 4700+ projects, and clients in 58+ countries.

biostatistics consultationclinical developmentCMCFDA meeting preparationFDA submissionsnonclinical pharmacology/toxicologyquality systems & trainingregulatory operationsStaff augmentation

Boston Strategic Partners (BSP) is a consulting firm serving clients across the pharmaceutical, medical device, and diagnostics industries, from startups to Fortune 100 companies. Founded on principles of efficient professional services, business and clinical expertise, and a broad suite of services, BSP helps clients realize clinical, financial, and regulatory objectives.

app developmentArtificial IntelligenceBusiness and Clinical Strategyclinical trial supportCRO servicesdata visualizationfinancial advisoryhealth-economic modelinghealth economics and outcomes researchMedical and Technical Communicationsreal-world data analytics

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 submissionsreimbursement and market accessSaMD development

CCKr Therapeutics is a drug development company focused on transforming GI cancer and fibrosis treatment. Its lead asset, Proglumide, is a small molecule repurposed drug with oral bioavailability that antagonizes the CCK-B receptor and blocks CCK-A and CCK-B receptors. Target indications include pancreatic cancer, chronic pancreatitis, liver fibrosis, and pain management. The company reports early Phase 1 results and ongoing Phase 1/2 trials, with fast-track potential.

clinical trials (Phase 1/2)drug development

Celdara Medical transforms academic innovations into medicines, partnering with inventors and research institutions in the US, EU, and beyond. It provides developmental, financial, and business acumen to bridge discovery and clinical impact, building academic and early-stage innovations into high-potential biotechnology companies.

biotechnology research and developmentpreclinical and clinical strategyrisk managementseed funding

Certara provides drug development solutions including predictive simulation, data-driven modeling, and AI tailored for drug development. The company offers software, services, and consulting across discovery, preclinical, clinical, regulatory, and market access phases, serving biotech, pharma, and CROs. Certara has over 1,550 employees in more than 30 countries, over 28% of whom have PhDs.

AI for life sciencesbiometrics and data sciencebiosimulationdata standardization and validationeCTD submissionsmodel-informed drug developmentmodeling and simulationPBPK modelingreal-world evidence

ClinQure is a contract research organization focused on the clinical, quality, and regulatory aspects of medical device and pharmaceutical development. It emphasizes a partnership-driven model with personal engagement and customized solutions, and offers clinical research solutions, quality management services, and regulatory services.

clinical researchcompliance assurancepresubmission supportQuality Management

Concept to Market LLC is an advisory firm that helps life science innovators secure non-dilutive funding to bring pharmaceutical, biotech, and medical technologies to market without giving up equity. With over 25 years of experience and $3B+ in non-dilutive funding secured, it provides strategic, end-to-end support across government grants, public-sector contracts, and foundation-backed capital, from proposal development to post-award compliance and commercialization strategy.

commercialization strategycompliancefunding strategyprogram managementproposal development

Crimson Scientific develops a reusable, non-adhesive ECG pad that simplifies 12-lead acquisition into a single step. The pad features pre-positioned electrodes, is compatible with existing ECG machines, and enables fast, repeatable use without skin preparation. Founded by MIT engineers and physicians, the company is supported by Baxter and Endeavor Health, with multiple health systems preparing pilot programs.

ECG pad designhardware developmentSystems Engineering

Deffai provides AI-assisted regulatory intelligence validated by former FDA reviewers. The company is built by former FDA reviewers and decision-makers across CBER, CDER, and CDRH with 100+ years of experience across cell & gene therapy, including mRNA, AAV, ADC, immunotherapies for vaccines, oncology, regenerative medicine and tissue engineering for medical device and combination products. Deffai is an independent firm and is not affiliated with the U.S. Food and Drug Administration.

AI-assisted regulatory assessmentFDA meeting representationFDA submission review

DIMERx, Inc. is a clinical-stage biopharmaceutical company developing first-in-class, covalently linked dimer-based therapeutics to address major public-health challenges in pain management and the opioid crisis. Its pipeline includes DMX-101 (buprenorphine dimer, Phase 2), DMX-201 (arginine-agmatine dimer, IND-enabling) and DMX-105 (acetaminophen dimer, IND-enabling). Development is supported by competitive NIH awards, including an $18M mandate.

clinical developmentcovalent dimerization technology platformdrug discovery and developmentmedicinal chemistrypreclinical development

EcoVantage is a boutique ecological advisory firm specializing in environmental markets, mitigation banking, ecological restoration, regulatory strategy, and natural resource project development. It helps clients navigate complex environmental challenges by combining scientific expertise with practical business and regulatory insight. The firm is certified by the U.S. Small Business Administration as a Women-Owned Small Business (WOSB) and HUBZone Small Business.

ecological restorationenvironmental marketshabitat assessmentsmitigation bankingnatural resource project developmentpermittingwetland delineation

EEA Innovations specializes in medical device development, delivering engineering, regulatory, testing, and commercialization services. With over two decades of experience, the team has developed 10+ FDA-cleared products and operates within a QMS aligned with ISO 13485 and IEC 62304, partnering with innovators to fast-track medical technologies, software, and devices from concept to commercialization.

3D printingbiological evaluation (ISO 10993)design for manufacturingdesign transferEMC safety testingmachiningmedical device developmentmoldingpackaging designpackaging validationprocess validationQMS (ISO 13485)rapid prototypingrisk management (ISO 14971)software development (IEC 62304)sterilization validationsupplier qualificationusability testing (IEC 62366)verification and validation