Regulatory Affairs

Aisa Pharma is a privately held, clinical-stage biopharmaceutical development company dedicated to bringing new disease-modifying treatments to patients with rare serious diseases. It focuses on repurposing and optimizing select calcium channel blockers, and its lead program is developing AISA-021, an oral therapy targeting N-type calcium channels for Raynaud's phenomenon associated with systemic sclerosis (scleroderma). The company is headquartered in Boston, Massachusetts, with additional presence in Sydney, Australia.

clinical developmentclinical operationsCMCdrug developmentrepurposing and optimizing calcium channel blockers

Allied Technologies and Consulting (ATC) is a Minority and Service-Disabled Veteran-Owned Small Business (SDVOSB) founded in 2001 by two retired Army officers, Intisar Abbasi and Dr. Dale Vander Hamm. ATC is a professional services company serving government and commercial clients in four focus areas: Program Management; Technical & Scientific Services; Information Technology; and Operations, Logistics, & Lifecycle Management.

Biostatistics and Data Managementclinical trial supportconfiguration managementInformation Technologymanagement consultingOperations, Logistics, & Lifecycle ManagementProgram Managementrisk and threat assessmentssupply chain managementTechnical & Scientific Servicesvulnerability assessments

Alphyn Biologics is a clinical-stage dermatology life science company developing first-in-class Multi-Target Therapeutics (MTT) for severe and prevalent skin diseases based on its Zabalafin Platform (AB-101 Platform). Its lead product candidate, zabalafin hydrogel (AB-101a), is in development for mild-to-moderate atopic dermatitis and has completed a Phase 2a clinical trial. The company became operational in March 2020 and is based in Annapolis, Maryland and Cincinnati, Ohio, with an Australian subsidiary and a European presence in Vienna, Austria.

clinical trialsdrug developmentQuality Systems Management

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 strategyResearch Protocol Designrisk managementstakeholder engagementstrategic planningTelehealth Solutions

Apnar Pharma LP is a privately owned, rapidly growing pharmaceutical company engaged in the acquisition, licensing, development (ANDA), sales, manufacturing, marketing and distribution of generic pharmaceuticals, drugs, and OTC non-prescription items for the U.S. market. It is a NABP Verified-Accredited Wholesale Distributor (VAWD) compliant with Federal and State DSCSA rules.

analytical method developmentblister packagingbottle packagingdistributionformulation developmentimpurity profilingmanufacturingpreformulation studiesquality assurancequality controlsecondary packagingvalidation services

Archer Public Affairs (APA) is a bipartisan government and regulatory affairs firm serving New Jersey, Pennsylvania, Delaware, and beyond. The firm helps organizations navigate public policy, regulation, and politics, providing strategic guidance and advocacy at local, state, and regional levels. It is an affiliate of Archer & Greiner, a regional law firm.

campaign finance compliancecoalition buildingcrisis managementcybersecurity advisorygrassroots advocacylegislative draftinglobbyingpolicy advisoryprocurement strategypublic-private partnership advisorystakeholder engagement

Arroyo Research, Inc. (ARI) provides quality customized Phase I-Phase-IV clinical trial services, connecting sponsors with experienced, prescreened investigators and sites, and offering site feasibility and patient recruitment tools.

biostatisticsclinical monitoringclinical operationsconsultingdata managementInvestigator Selectionmedical devicesproject managementquality assurancetechnology

Arsenal Medical is a medical device company that develops biomaterials-based products. Its platform includes NeoCast, an injectable shear-responsive material for deep neurovascular occlusion, and ResQFoam, a rapidly expanding hydrophobic foam designed to control hemorrhage in abdominal trauma. The company was founded by Carmichael Roberts, Robert Langer, and George Whitesides, and is led by CEO Upma Sharma.

biomaterials developmentclinical trialsmedical device development

ASRT, Inc. is a certified small business founded in 2017 and incorporated in Georgia that offers services in health science, information technology, and other related fields to federal and state governments, the private sector, and other organizations domestically and internationally. Its mission prioritizes improving health, well-being, and cutting-edge science and technology.

bioinformaticsCustom Scripting and Algorithm Developmentdata managementDiagnostic Development SupportEpidemiology and Molecular Epidemiologyhigh-performance computingmathematical modelingMolecular Assays DesignsNGS and Long Read TechnologiesOmics (Genomics, Transcriptomics and Proteomics)protein purificationquality assurance/quality controlRecombinant Protein DesignScientific staffingStatistics and BiostatisticsWorkforce Training & Learning Modules

Atavistik Bio is a clinical stage biotechnology company developing novel allosteric therapeutics. Its approach enables selective modulation of disease-causing proteins. The company is advancing multiple programs, including its lead asset ATV-1601, an oral allosteric AKT1-selective inhibitor for Hereditary Hemorrhagic Telangiectasia (HHT), and a JAK2 V617F mutant-selective inhibitor program for myeloproliferative neoplasms. It has built a versatile discovery platform that identifies functional pockets across protein classes, with an internal focus on rare

allosteric drug discoverycheminformaticsclinical developmentCMCDMPKmedicinal chemistrytranslational research

BalinBac Therapeutics, Inc. is a clinical stage biopharmaceutical development company headquartered in Princeton, New Jersey, focused on rapidly bringing both repurposed and new antivirals and antibiotics to market. It began working on coronavirus device and drug delivery solutions in January 2020, aiming to provide life-saving drugs to COVID-19 victims through outpatient treatment and to commercialize antivirals and delivery systems for broad global accessibility.

clinical developmentdrug developmentlicensing and technology transfermedicinal chemistry and drug discoveryproject managementrespiratory drug delivery

bioLytical Laboratories Inc. is an industry leader in manufacturing rapid in vitro diagnostic tests focusing on infectious diseases. Founded in 2002, it develops products in-house and manufactures them in an MDSAP: ISO 13485-certified facility in Richmond, British Columbia, Canada. Its INSTI platform provides the world's fastest HIV test with results in one minute or less, and the iStatis lateral-flow platform detects infectious diseases through antibodies and antigens.

flow-through technologyinfectious disease testinglateral flow test platformManufacturing & QCresearch & development

BiomEdit is an animal health biotechnology company developing Programmable Veterinary Biologics, beneficial bacteria engineered to perform specific biological functions in livestock and pets. Located inside the laboratory facilities of the Indiana Biosciences Research Institute in Indianapolis, Indiana, the company applies microbial discovery, strain engineering, computational biology, and product development to address infectious disease, chronic disease, and sustainability challenges in animal health.

AI/MLcommercializationcomputational biologymicrobial discoveryproduct developmentsequencingstrain engineering

CCS Associates (CCSA) is a small business providing leading-edge scientific services in product discovery and development to government agencies and the pharmaceutical and biotech industries. It is a full-service CRO offering services from discovery to approval, with more than 40 years of client success. CCSA was founded by Caroline C. Sigman, PhD, and its projects have led to 5300+ IND, NDA, CTA, DMF, IDE, and INAD submissions.

bioinformaticsclinical trial monitoringeCTD publishingpharmacologypharmacovigilancescientific and medical writingstrategic planningtoxicology

Clinical Research Strategies is a US-owned and operated contract research organization and executive management consultancy for start-up and mid-size life sciences companies. Headquartered in Wexford, PA, it helps clients instill fiscal discipline and reduce risks in clinical development, corporate affairs, and quality assurance programs, offering project-specific, fit-for-purpose, ad hoc consulting and clinical trial staffing.

clinical trial staffingcompliance and due diligencecontract research organization servicesdocument redactionexecutive management consultinghuman factors studiesquality assurancetech transfer advisory

Cormac Life Sciences is a clinical research organization specializing in biosurveillance, basic and translational sciences, clinical research, and essential support services. It is a New York limited liability company, licensed to do business in New York State and eligible to provide services nationally, majority-owned by a service-disabled veteran and headquartered in New York State. It is a verified Service-Disabled Veteran-Owned Small Business and a certified New York State Service-Disabled Veteran Owned Business.

analytic assay development/validationbiosurveillanceclinical field site developmentclinical vaccine/drug developmentexperimental human infection studiespre-clinical vaccine/drug developmentquality assurance

Cortene is a clinical stage biopharmaceutical company developing a patent-protected, peptide-based treatment for brain-centric acquired chronic diseases (ACDs). Its hypothesis centers on dysregulated serotonin signals driven by upregulated CRFR2, which it aims to reverse using agonist-mediated receptor endocytosis. The hypothesis has been partially proven in a proof-of-concept Phase 2 clinical trial, and the company plans trials in Parkinson's and Alzheimer's.

clinical trialsdrug developmentpeptide manufacturing and formulation

Cycle Pharmaceuticals is a pharmaceutical company established in 2012 that provides treatments and support services for patients with rare and life-changing conditions in oncology, neurology, metabolics, and immunology. It focuses on improving medication forms and offering individualised patient support, including a Free Goods Programme for patients unable to pay for rare disease medication.

improving medication forms (smaller tablets, temperature stable, dissolvable tablets)patient support servicespharmacovigilanceproduct launch

Homeadmin2025-05-07T17:04:32+00:00 DP Clinical Has Been Providing CRO Services for Over 30 Years!Whether you need a full complement of clinical trial services or only specific service offerings, we will provide the expertise, flexibility, and innovation to meet your study needs. Loading... We are proud to celebrate a major milestone for our client, Spectral AI, following the FDA’s De Novo clearance of its Deep View® System, an innovative AI-powered imaging technology designed to support burn wound assessment and treatment decisions. Learn More We're proud to share that our Director of SCI Programs, Jim Hamer, and Medical Advisor, Dr. Lisa Ruppert, were honored with the FASIA Award at the American Spinal Injury Association (ASIA) Annual Meeting 2026! Learn More Flexible CRO providing full and functional services since 1994. CRO specializing in Critical Care, Dermatology, Infectious.

biostatisticsclinical trial monitoringdata managementmedical writingPharmacovigilance and safetyproject managementquality assurance

Dynamic Planning + Science bridges natural and built environments, delivering innovative solutions that promote resilience, safety, and sustainable growth. The company specializes in Comprehensive Planning, Regulatory Affairs, Emergency Management, and Data Visualization, and is dedicated to empowering communities with tailored solutions, professionalism, and commitment to success.

Comprehensive PlanningData VisualizationEmergency Management

eRIC SOLUTIONS is a full-service CRO and regulatory affairs partner founded in 2016 and headquartered in Plantation, Florida, with operations in India and partners in Argentina, Hungary, Romania, and Australia. It runs ICH-GCP Phase I–IV clinical trials and the data, biostatistics, safety, and regulatory work behind them for pharma, biotech, and medical-device sponsors in the US, Europe, and Asia.

AI agents for clinical trialsbiostatisticsclinical trial managementdatabase designdata managementmedical writingmonitoringpharmacovigilanceproject management

Extremity Medical develops novel technologies that enhance the mechanical properties of medical devices for extremity orthopedic procedures. Founded in 2008 by Matt Lyons, the company specializes in next-generation products for fusion, fixation, and motion preservation systems tailored for the upper and lower extremities, and is located in Parsippany, NJ.

in-house cadaver labmedical device engineeringproduct developmentquality managementsurgeon training

Fannin is a Houston-based early-stage life sciences product development group established in 2014. It in-licenses promising early-stage therapeutic and medical device technologies and serves as both management team and early investor, collaborating with academic inventors to advance technologies using investor and grant funding. Fannin also runs a Product Development Associate Program and internship program training scientists in life-science product development.

biomedical asset developmentbusiness developmentcommercializing academic researchgrant fundingintellectual property managementproduct development

Frestedt Incorporated provides clinical, regulatory, quality and biomedical engineering expertise for the biotechnology, pharmaceutical, medical device and in vitro diagnostics industries. It is the parent company of Alimentix, which provides food-related support, and the Frestedt Learning Center, which offers customized training events. Founded on February 26, 2008, the company runs clinical trials, negotiates with regulatory authorities, builds quality systems and provides biomedical engineering solutions.

biomedical engineeringclinical researchclinical trial executionquality systemstechnical writingtraining