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Explore the leading pharmaceutical consulting firms across the U.S., featuring specialized services in biotechnology, regulatory compliance, and drug development. From Tulip Medical Consulting's strategic growth initiatives in Washington to Firma Clinical Research's innovative clinical solutions in Illinois, these firms offer a wide spectrum of expertise. Companies like Luye Pharma USA in New Jersey and VivoSense in California blend advanced technology with healthcare solutions, making them pivotal players in the pharmaceutical landscape.
ELIQUENT Life Sciences specializes in biotechnology research, offering expert regulatory consulting services that streamline the drug approval process. By uniting multiple global regulatory consultancies, it provides a comprehensive and integrated approach to navigating the complex regulatory landscape for pharmaceutical, biotechnology, and medical device industries.
Successful Strategies for Life Sciences
🇺🇸 Boston, Massachusetts 02110, USA dynamic consulting firm in the pharmaceutical manufacturing industry, SSSLS specializes in transforming R&D processes and fostering partnerships to enhance efficiency and inclusivity in clinical trials, particularly for underrepresented communities. Their innovative, process-centric solutions guide clients through capital raising to regulatory approval, revolutionizing the life sciences landscape.
Clinical Trials GPS
🇺🇸 4520 Main St Kansas City, Missouri 64111, USClinicalTrialsGPS specializes in facilitating access to clinical research trials, enhancing patient recruitment, and connecting individuals with nearby research sites. By guiding users through the complexities of clinical trials, it plays a vital role in the drug development process and FDA approval, ensuring informed participation in innovative health solutions.
Heart Failure Collaboratory
🇺🇸 Fairfax, Virginia 22031, USThe Heart Failure Collaboratory is an academic consortium focused on enhancing the ecosystem of heart failure clinical research through innovative approaches in digital health, regulatory policy, and streamlined research processes. By fostering collaboration among stakeholders, it aims to improve trial efficiency and develop effective therapies for heart failure.
Hurley Consulting Associates Ltd.
🇺🇸 25 DeForest Avenue Summit, NJ 07901, USHurley Consulting Associates Ltd. specializes in providing comprehensive consulting and contract research services within the pharmaceutical manufacturing industry, focusing on regulatory strategies and submissions throughout the entire IND to NDA process. With a strong emphasis on data analysis and integration of nonclinical and clinical evaluations, the firm is recognized for its high-quality expertise and innovative approach to supporting health sciences clients.
Specializing in biotechnology research, this firm provides expert consulting services in global health and regulatory affairs, focusing on gene therapies, biologics, and complex drug development processes. With over 15 years of experience, it offers innovative regulatory strategies and compliance solutions tailored for the pharmaceutical and biotech sectors.
National Board of Early Access Medicine
🇺🇸 Bay Area San Francisco, CA, USNBEAM specializes in providing education and policy support for physicians and therapeutic companies regarding Expanded Access clinical trials, focusing on pre-first-approval access to new medicines. As the oldest organization in this field, it plays a pivotal role in advancing access to innovative treatments, particularly for conditions like Amyotrophic Lateral Sclerosis.
WideTrial, Inc. specializes in creating and managing Expanded Access trials, enabling a broader range of seriously ill patients to access pre-market clinical trial medicines. By partnering with drug and device manufacturers, it offers innovative turn-key solutions that facilitate pre-approval treatment access and generate valuable real-world clinical data.
BLA Regulatory specializes in biotechnology research, offering tailored regulatory affairs guidance to streamline the drug development process from initial strategy to market approval. With over 130 years of combined experience, the team leverages deep expertise in various aspects of drug development to ensure compliance and facilitate efficient regulatory evaluations.
Smithers - Pharmaceutical Development Services
Smithers specializes in bioanalytical services for the pharmaceutical manufacturing industry, focusing on the development of large molecules and cell and gene therapies throughout all phases of drug development. Their innovative approach includes method development, validation, and comprehensive sample analysis, supporting over 100 clinical trials in compliance with FDA regulations.
PharmaPro Consulting
🇺🇸 4 Cruiser Court Hillsborough, New Jersey 08844, USPharmaPro Consulting specializes in biotechnology research, providing expert consultancy services to accelerate the development of new pharmaceutical agents from Investigational New Drug (IND) applications to New Drug Applications (NDA) and Biologics License Applications (BLA). With a focus on regulatory strategy, clinical pharmacology, and innovative modeling techniques, it offers a comprehensive approach to navigating complex regulatory landscapes and advancing drug development efficiently.
Organon Clinical Trials specializes in pharmaceutical manufacturing, focusing on conducting clinical trials to advance medical research and innovation. Their dedicated platform emphasizes transparency and accessibility for U.S. residents participating in clinical studies.
Speid & Associates, Inc.
🇺🇸 665 San Rodolfo Drive Solana Beach, CA 921024, USSpeid & Associates, Inc. specializes in regulatory and drug development consultancy within the pharmaceutical manufacturing industry, focusing on expediting the market access of therapeutics, including drugs, biologics, and diagnostics. Their innovative approach emphasizes collaboration and expertise across a wide range of therapeutic areas to accelerate the commercialization process.
SYNERGY GLOBAL REGULATORY AFFAIRS CONSULTANCY, INC.
🇺🇸 Boston Boston, MA, USSpecializing in global regulatory affairs, quality assurance, and post-market compliance, this firm offers strategic consulting services tailored for clinical trials and research, ensuring adherence to industry standards and enhancing operational effectiveness.
Clinical Research Strategies, LLC
🇺🇸 6400 Brooktree Court Suite 240A boutique start-up specializing in biotechnology research, offering tailored clinical research and regulatory strategy management services. It focuses on simplifying complex regulatory and research processes for life science executives and entrepreneurs, enhancing their ability to navigate clinical trials and improve product commercialization outcomes.
Rubix LS is a pioneering entity in biotechnology research, specializing in patient-centered clinical and drug development through the innovative use of personalized AI and extensive patient data. By focusing on inclusivity and forming strategic alliances, it enhances the efficiency of navigating clinical trials and securing FDA approvals, particularly in addressing rare diseases.
R & C Consulting Group LLC
Specializing in biotechnology research, this organization offers comprehensive regulatory affairs, clinical trials management, and quality system services to facilitate the development and market entry of medical devices, biologics, and pharmaceuticals. Their innovative approach includes providing virtual regulatory and clinical affairs departments, ensuring clients receive tailored support throughout the product life cycle.
Indevric Consulting LLC
🇺🇸 Indevric Consulting LLC Rapid City, SD, USIndevric Consulting specializes in providing regulatory guidance and strategic consulting services to small to midsize pharmaceutical and biotech firms, focusing on clinical and nonclinical development across various therapeutic areas, including oncology and rare diseases. With a strong emphasis on facilitating successful health authority interactions, it offers innovative solutions tailored to the unique needs of drug development.
Palo Verde Clinical Research specializes in research services within the pharmaceutical industry, offering over 25 years of expertise in drug discovery, clinical trials, and cGMP manufacturing. The firm uniquely supports sponsors in bringing drugs to market, raising capital, and preparing for acquisition, ensuring tailored solutions to meet diverse client goals.
Frontier Clinical Research
🇺🇸 100 Ridge View Drive Unit 4Frontier Clinical Research specializes in recruiting patients for paid clinical trials, accelerating the approval of innovative medications. By operating multiple research sites, it enhances access to cutting-edge medical advancements in the region.
Luye Pharma USA Ltd. specializes in pharmaceutical manufacturing, focusing on innovative research and development alongside comprehensive clinical and regulatory strategies. With a global presence and a commitment to advancing healthcare solutions, it serves as a pivotal hub for clinical and regulatory operations in the United States.
East Tennessee Clinical Research, Inc.
🇺🇸 Copper Ridge Farm Somewhere, TN 37777, USSpecializing in veterinary contract research, this organization provides clinical development services focused on GCP and GLP studies for horses, livestock, and companion animals, contributing to the approval of numerous veterinary pharmaceuticals. With a commitment to regulatory compliance and innovative study designs, it offers unique expertise and dedicated facilities to meet industry challenges.
Firma Clinical Research
🇺🇸 881 Busse Rd Elk Grove Village, Illinois 60007, USFirma Clinical Research is a global contract research organization specializing in drug development, offering innovative solutions such as in-home patient visits, advanced data management, and regulatory consulting. Their collaborative approach, backed by extensive clinical expertise, accelerates the creation of safe and effective treatments in the pharmaceutical, biotechnology, and medical device sectors.
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