We deliver innovative, practical solutions for your life science challenges.

WHAT WE DO

It takes rigorous science, innovative strategies, and world-class expertise to tackle difficult life science issues and keep your projects moving forward. That’s what BlueRidge Life Sciences provides.

We offer integrated, comprehensive solutions that address complex technical, clinical development, and safety and regulatory challenges, leveraging our deep scientific, medical, and regulatory expertise and real-world experience. Our goal is to help you complete projects efficiently and with less risk, leading to solutions for a healthier and safer world.

With a broad range of renowned scientific, medical, regulatory, and engineering specialists under one roof, we streamline your project and reduce your workload, so you can make sound, science-based decisions about human and environmental health issues.

BlueRidge Life Sciences is a growing family of companies providing a comprehensive suite of life sciences services, spanning toxicology, regulatory science, risk assessment, epidemiology, biostatistics, engineering, clinical research, health economics, pharmaceutical commercialization, and environmental consulting. Across these specialized areas, we collaborate to deliver science-driven solutions that support industries including pharmaceuticals, biotechnology, medical devices, chemicals, foods and consumer products. Our collective expertise helps clients navigate regulatory requirements, assess safety and efficacy, manage risks, and optimize pharmaceutical commercialization strategies.

If you’re ready to achieve your life science goals, there’s no better partner than BlueRidge Life Sciences.  

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WHAT WE DO

For therapeutic product development, we offer a cross-division integration of expertise to support pharmaceuticals, biologics, and medical device development from discovery through commercialization. 

Clintrex Research provides strategic guidance on CNS therapies from pre-clinical trial design through regulatory submissions, and investor strategies. EpidStrategies uses rigorous methodologies for evidence planning, integration, and synthesis to support and advance drug and medical device development, treatment, and safety. HEORStrategies  and BlueRidge Pharmaceutical Commercialization delivers health economics and outcomes research (HEOR) to support value demonstration, pricing strategies, and reimbursement planning and to define the value of therapies for payers, patients and providers. Modality Solutions ensures the integrity of temperature-sensitive therapeutics through engineering solutions for cold chain logistics. Suttons Creek Inc. plays a key role as the device team for pharma, offering specialized consulting in medical device development, combination products, and regulatory strategy. Our expertise helps ensure that drug-delivery systems, diagnostics, and device-based therapies meet rigorous industry standards, regulatory requirements and ultimately reach the patients who need them. 

ToxStrategies provides a comprehensive range of services in nonclinical toxicology for clinical development of biopharmaceutical (innovator and biosimilars) and pharmaceutical drug candidates. Together, we provide an integrated, end-to-end approach to life sciences consulting, supporting clients in developing, validating, and bringing therapeutic innovations to market efficiently and safely.

Technical Services Across the Therapeutic Product Development Lifecycle

BlueRidge supports the most challenging phases of drug development, including nonclinical safety, clinical development, regulatory strategy and commercialization. We have solved some of the most difficult challenges during the pIND, IND, EOP2, Pre-NDA and NDA phases of development.

Our world-renowned team of physicians, scientists, engineers, health economists, and pricing and pharmaceutical commercialization experts brings deep expertise in both traditional medications and innovative therapeutics—including combination drug/biologic + device products, cell and gene therapies, monoclonal antibodies, and small-molecule drugs. BlueRidge leverages experience across a full spectrum of therapeutic areas, including central nervous system (CNS) disorders and pain, rare diseases, infectious diseases, oncology, ophthalmology, and autoimmune and inflammatory conditions. Additionally, we utilize advanced simulation methodologies to perform transport validation testing on novel, fragile, or temperature-sensitive therapeutics, ensuring they meet rigorous regulatory requirements during transit.

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Epidemiology and Biostatistics

BlueRidge epidemiologists and biostatisticians provide innovative and robust solutions for conducting, evaluating, and interpreting epidemiological studies in the pharmaceutical, medical device, nutritional product, and environmental chemical industries. Our research frequently results in peer-reviewed publications and presentations at scientific conferences and is also used in numerous regulatory documents in the US and Europe.

Our scientists are well versed in evidence generation, real world data and evidence (RWD/RWE), value propositions, study design and protocol development, statistical analyses, regulatory submissions, and publication strategies.

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Exposure Sciences

Our scientists, engineers, and health physicists are recognized leaders in assessing exposure to chemicals and radionuclides in air, water, soil, sediments, and biota, as well as in food and consumer products. In addition, we provide customized industrial hygiene and occupational safety services.

BlueRidge has extensive experience in designing and implementing exposure monitoring studies, compiling and analyzing large environmental datasets, and collaborating with federal, state, and local regulators within regulatory programs such as Superfund and TSCA. We leverage state-of-the-art tools to perform quantitative modeling and apply GIS methods to assess and visualize exposure risks from air toxics and other environmental releases. Our expertise also includes exposure reconstruction, exposure simulation studies, and research on bioaccessibility and bioavailability.

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Risk Assessment, Toxicology, and Health Science Research

BlueRidge toxicologists, scientists, and engineers bring decades of experience and PhD-level expertise in designing research programs and conducting risk assessments for environmental and occupational exposures, as well as chemicals in foods, consumer products, and over-the-counter medications.

We are recognized for tackling society’s most complex challenges, including assessing cumulative health risks for vulnerable populations and utilizing new approach methods (NAMs) to reduce reliance on animal models in research and human health risk assessment applications. Our team has world-renowned expertise in conducting systematic literature reviews and evidence-based toxicology.

BlueRidge employs physiologically based pharmacokinetic (PBPK) models and advanced in silico tools for modeling metabolism and quantitative structure-activity relationships (QSAR), refining risk assessment methods to enhance decision-making and address regulatory and legal challenges. Additionally, we conduct dose-response modeling, mode-of-action analyses, and adverse outcome pathway studies while designing and overseeing research that supports safety mechanisms of action.

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Food and Consumer Product Safety

BlueRidge toxicologists and regulatory scientists assist food and consumer product companies in ensuring safety, maintaining compliance, and substantiating claims, including those related to sustainability.

We conduct comprehensive safety and risk assessments for foods, dietary supplements, cosmetics, personal care products, and raw ingredients, including complex botanicals and mixtures. Our team has deep expertise in regulatory expectations, including the Food Safety Modernization Act (FSMA) and the Modernization of Cosmetics and Regulation Act (MOCRA). Additionally, we provide support in landscape and horizon scanning topics and offer extensive experience in food safety plans, specification considerations, food defense risks, and validation assistance for food processing operations.

SECTORS WE SERVE

BlueRidge continues to drive innovation on behalf of industry leaders in pharmaceutical, food, consumer product, chemical, energy, manufacturing, and other businesses.

  • Developers of innovative drug/biologic + device products turn to BlueRidge for support from planning through commercialization, reducing costs and increasing revenue.

  • Makers of ingredients, food products, and dietary supplements rely on BlueRidge to assess and ensure safety, substantiate health claims, and evaluate regulatory compliance risks. 

  • State and federal agencies select BlueRidge for our deep scientific expertise supporting safety assessments in pharmaceutical products and for the study of challenging environmental issues related to endocrine disruption and environmental exposure to chemicals.

  • A broad spectrum of leading companies in various industries, regional entities, and trade associations partner with BlueRidge for scientific services that address human and environmental health concerns.

  • Attorneys requiring scientific expertise to understand exposure, toxicology, and health risk tap BlueRidge scientists to conduct in-depth research into causation analysis.

  • Leading consumer product companies trust BlueRidge toxicologists to conduct safety and risk assessments that satisfy regulatory requirements on existing and newly developed products.

  • Animal feed and pet food companies turn to our toxicologists for comprehensive safety assessments, regulatory strategies, and assistance with product claims substantiation.

  • Pharmaceutical and biotech companies choose BlueRidge to support their pre-clinical and clinical development, distribution, regulatory and commercial activities to seamlessly get new and life-changing interventions to those who need them.

  • Academic institutions and organizations partner with BlueRidge to strengthen study design, enhance research methodologies, and garner regulatory approval to translate new discoveries into meaningful health solutions.

INDUSTRY IMPACT

Our highly experienced world-renowned scientists, physicians, and engineers, help premier companies get further faster, bringing their life science goals to fruition.

WHAT OUR CLIENTS SAY

  • Acadia Pharmaceuticals

    "The team played an integral part in the project that ultimately led to the launch of Daybue (trofinetide). They demonstrated expert knowledge of the entire cold chain process and gave us advice, guidance and assistance that facilitated us to get FDA approval. We can’t thank them enough and look forward to working with them in the future."

  • Annexon Biosciences

    “Annexon is excited to see that ToxStrategies LLC and Clintrex Research LLC are now operating under one umbrella as part of BlueRidge Life Sciences (BRLS). Bringing experts in the non-clinical and clinical space under one umbrella offers clients unparalleled expertise in this space. ToxStrategies has developed and implemented the non-clinical strategies for Annexon since 2014 on all of our key programs. This includes multiple unique modalities and routes of administration in a variety of complement-mediated diseases Likewise, Annexon has been working with Clintrex since 2018 on clinical development and regulatory strategy challenges for our lead programs, which overlap with those that ToxStrategies has supported. The level of expertise, dedication, out-of-the-box thinking, and solution-oriented approach on both teams has been first in class."

  • Cerevance

    “We’ve had the pleasure of working with Clintrex, a BlueRidge Life Sciences Company, for over three years, and they’ve truly become invaluable thought partners in our journey to develop our Parkinson’s medication. Their expertise has been a game-changer in helping us map out a clear development pathway, from interpreting complex clinical and preclinical data to providing sharp insights that keep us on track. Beyond that, they’ve been hands-on with our Phase 2 and 3 studies—running the enrollment authorization committee, digging into anomalous data checks, and just being an all-around great addition to the team. When we’ve needed them, they’ve also stepped up with smart, reliable regulatory strategy support. BlueRidge Life Sciences doesn’t just deliver; they elevate everything we do and are a great partner who has been invested in our success.”

    Craig Thompson, CEO

  • Duck Creek Energy

    “Nature’s Own Source, LLC and Duck Creek Energy, Inc have been working with BlueRidge Life Sciences ToxStrategies engineers and scientists for over ten years across multiple disciplines including Radiologic Risk Assessment and Environmental Risk Assessment, and the team provides quality risk assessment and support. Their evaluations have led to successful guidance, direction and outcomes. We appreciate the quality of support and service received with our long-term relationship.”

    David Mansbery, President

  • Novelis

    “ToxStrategies, a BlueRidge Life Sciences Company has been a valuable technical and compliance resource to help Novelis maintain compliance with internal and external environmental regulations and accounting standards. Their technical project reviews have helped drive compliant, sustainable strategies towards project closure.  They have also been a valued resource for Novelis’ financial accounting team to complete accounting standards.  ToxStrategies’ team are a pleasure to work with and bring value-added insights to help maintain compliance and complete our sustainability vision.”

    Jeff Drzewiecki, Environmental Remediation Manager

  • Ovid

    “When Ovid’s vision expanded into brain diseases more broadly, we needed a deeply experienced partner to help us develop a creative clinical and regulatory strategy across our pipeline. I have worked with Clintrex for nearly ten years through several companies and immediately reached out to the Clintrex Managing Principal, Karl Kieburtz, MD  to put into place a relationship with Clintrex. Over the past year, their level of experience, depth and breadth of clinical and regulatory knowledge, flexibility, dedication, innovative thinking, and solution-oriented approach has been remarkable and has contributed to rapid progression of our clinical programs. We have recently expanded this relationship to include experts at ToxStrategies, who are helping us shape our non-clinical studies for success. Clintrex and ToxStrategies have become a critical part of our teams. This group is not just smart and experienced, they are good, curious, open-minded people with high integrity.”

    Amanda Banks, Chief Development Officer

  • PhotoPharmics

    “Since 2016 the BlueRidge Life Sciences Clintrex team has been supporting PhotoPharmics® with our clinical development program, regulatory strategy and securing investors for our FDA Breakthrough product, Celeste® specialized phototherapy for both motor and non-motor symptoms of Parkinson’s Disease and for future treatment in Huntington’s and Alzheimer’s. They have become an integral part of the PhotoPharmics team, whether it is solving complex clinical and regulatory challenges, explaining the science and clinical outcomes of our novel therapy to investors, or introducing us to clinical, scientific and industry contacts. The level of expertise, depth and breadth of clinical and regulatory knowledge, flexibility, dedication, out of the box thinking, and solution-oriented approach has been remarkable.  With the support of the Clintrex team we look forward to successfully completing our FDA pivotal trial, receiving FDA and CE market authorizations and providing access to Celeste to improve the lives of patients throughout the world.”

    Kent Savage, CEO

  • Purgo Scientific

    "Our BlueRidge Life Sciences regulatory consultant's expertise has been invaluable in navigating the complex FDA landscape. Their deep understanding of regulatory process and strategic guidance has streamlined our medical device approval process, saving us time and mitigating risks. With their support and guidance, we are confidently advancing our product towards First in Human, while ensuring full compliance with FDA standards."

    Mike Benjamin, CEO & Executive Board Chair

  • Serina Therapeutics

    "We brought the team in as expert consultants during the pre-clinical phase of the development of our lead program. They provided essential insights into the interpretation of our data. We retained them for the design and conduct of our Phase Ia clinical program, and their input during discussions with the FDA was critically important. The successful enrollment and final study results from the first-in-man study of SER-214 in Parkinson's patients have positioned our company for continued success. We are now advancing our next Parkinson’s candidate with this team. They are simply the best."

  • Warren Steel

    “Over the past 4 years ToxStrategies, a BlueRidge Life Sciences Company has managed, as our client representative, a complex decommissioning and cleanup of a large, closed steel plant. They have expertly provided strategies, contractor oversight, and coordination and approval of plans under multiple regulatory programs, compliant with regulations, and protective of human health and the environment. We have been very pleased with their work and solution-focused approach. Thank you for the great work!”

    Daniela Rost, General Counsel