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Preclinical Research Services

With over 30 years of experience in drug development, Altasciences offers specialized preclinical research services. Our expertise spans a wide range of in vivo non-GLP and GLP safety assessment solutions in both rodent and non-rodent species to thoroughly evaluate pharmaceuticals, biologics, animal health products, agrochemicals, and biocides. Our scientific and regulatory teams develop customized research programs and conduct individualized preclinical studies to ensure that your IND/NDA-enabling toxicology, safety pharmacology, and laboratory studies comply with global regulations.

Connect with our seasoned experts for tailored advice on your preclinical research needs.

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  • EXPERIENCE
  • CAPABILITIES
  • STUDY TYPES
  • ANIMAL WELFARE
  • FACILITIES

Excellence in Preclinical
Drug Development Services

As a leading CRO, we provide a suite of unparalleled services, designed to streamline your path to market. Our team of skilled scientists and experts ensures quality data for your critical decisions, advancing your lead compounds to first-in-human trials and accelerating your drug development milestones.

Gain comprehensive insight with our detailed fact sheets. Covering everything on preclinical drug development, these resources offer an in-depth look at our capabilities in small and large molecule research services.

For more information, consult our:

  • Preclinical Drug Development Fact Sheet
  • IND-Enabling (Small Molecule) Fact Sheet
  • IND-Enabling (Large Molecule) Fact Sheet
  • Safety Pharmacology Fact Sheet
  • Nonclinical Safety Testing Guide

At Altasciences we have a unique approach to working with our clients. We treat our clients like colleagues and their projects as our own. It's the symbiotic win-win attitude that has created the foundation for our partnerships. With preclinical and clinical facilities in the United States and Canada, we are strategically located to support your project from lead candidate selection to proof of concept, and beyond. Led by a seasoned leadership team, our integrated solutions work hand in hand to ensure a rapid and smooth transition from safety testing to first in human trials. You'll see that you're working directly with a senior leadership within the organization. You also see that that senior leadership is able to make changes and to adjust to the needs of the client very rapidly. Our purpose-built preclinical facilities are located in Washington Pennsylvania, and Missouri, and are supported by over 500 employees. With 260 custom designed animal rooms. including European housing, our facilities provide the capacity to conduct safety testing efficiently and in compliance with worldwide regulatory requirements. Our preclinical team has expertise in both standard and complex study designs. Our study directors average over 15 years of experience and are personable and accessible. I am proud to lead a team of study directors that is engaged, passionate about the science, and committed to being the best partner. Our safety assessment solutions can be customized based on your needs. Our flexible approach, coupled with our scientific expertise, ensures your milestones are met and within budget. [Music] We have experience with both rodent and non-rodent species, and multiple routes of administration. [Music] With supporting capabilities under one roof, we produce quality and comprehensive data to accelerate your research. Our bioanalytical solutions are supported by a team of over 200 scientists, and our laboratories have the capacity to process over 60,000 samples a month. We have board-certified anatomic veterinary pathologists on site who work closely with your team to ensure all study objectives are met. We follow a harmonized QA approach that is employed across our organization and quality metrics are reviewed and acted upon monthly at the executive management level. [Music] Our SEND team provides compliant data sets for studies required under SEND 3.0 and SEND 3.1. We have developed a leading animal welfare program that complies with regulatory requirements. But more than that, our program was founded on a culture of compassion, respect, and integrity Clients come back to work with us for a reason; because when they choose Altasciences as a partner, they know that we work really hard on their behalf. At Altasciences, we believe that every partnership is personal and that shared expertise, collaboration, and cohesion drive better results. We are... Altasciences.

 

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PURPOSE-BUILT
FACILITIES

700+

SAFETY STUDIES
COMPLETED ANNUALLY

800+

TEAM MEMBERS

Tailored Full-Service Preclinical CRO Solutions

Discover our extensive range of customizable preclinical CRO services. Our full-service offering, from formulation to bioanalysis and beyond, is designed to meet your unique project needs with precision. 

They include:

  • formulation
  • analytical chemistry
  • bioanalysis
  • PK/TK data analysis
  • immunohistochemistry
  • specialized necropsies
  • anatomic pathology
  • clinical pathology
  • SEND (standard for the exchange of nonclinical data)

Versatile Animal Models and Administration Routes

Leverage our expertise in a broad spectrum of animal models and routes of administration. From rodents to nonhuman primates, and oral to dermal administration, we ensure meticulous studies for every requirement.

SPECIES

  • rats
  • mice
  • guinea pigs
  • rabbits
  • swine
  • miniature swine
  • dogs
  • nonhuman primates
    (Cynomolgus, Rhesus, others upon request)

ROUTES OF ADMINISTRATION

  • oral
  • parental
  • infusion
  • ocular
  • dermal
  • implant
  • intravaginal and intrapenile
  • rectal

Preclinical Study Types

Working with a wide range of pharmaceutical companies from across the globe, our team of scientists and technicians has been conducting preclinical research for decades. Our safety testing services include the following study types:

  • Lead Optimization Studies

    LEAD OPTIMIZATION STUDIES

    LEAD OPTIMIZATION STUDIES

    We offer a comprehensive suite of lead optimization services in drug discovery to identify optimal drug candidates for clinical success.

    LEARN MORE
  • Dos Range Finding Studies

    DOSE-RANGE FINDING STUDIES

    DOSE-RANGE FINDING STUDIES

    Our dose range finding (DRF) and maximum tolerated dose (MTD) studies are tailored to your therapeutic area and help determine the accurate dose selection for your preclinical drug safety and efficacy studies.

    LEARN MORE
  • Preclinical Pharmacology Studies

    PRECLINICAL PHARMACOLOGY STUDIES

    PRECLINICAL PHARMACOLOGY STUDIES

    Our preclinical pharmacological studies predict biological effects of new therapeutic entities, supported by our extensive bioanalysis capabilities.

    LEARN MORE
  • Pharmacokinetics and Pharmacodynamics Studies

    PHARMACOKINETICS/ PHARMACODYNAMICS STUDIES

    PHARMACOKINETICS/ PHARMACODYNAMICS STUDIES

    Our team of scientists is adept at evaluating PK/PD parameters for the characterization of active substances on a test system and understands the importance of selecting the right candidates for preclinical drug development.

    LEARN MORE
  • Cell and Gene Therapy Development

    CELL AND GENE THERAPY DEVELOPMENT

    CELL AND GENE THERAPY DEVELOPMENT

    We offer comprehensive services, including reliable NHP supply, meticulously designed studies assessing safety, germline integration considerations, and pre-existing immunity, and extensive molecular and bioanalytical expertise to support your research.

    LEARN MORE
  • Pivotal Toxicology Studies

    PIVOTAL TOXICOLOGY STUDIES (acute, sub-chronic, chronic, carcinogenicity)

    PIVOTAL TOXICOLOGY STUDIES (acute, sub-chronic, chronic, carcinogenicity)

    Our full range of in vivo non-GLP and GLP preclinical evaluation studies in both rodent and non-rodent species thoroughly assess the safety of your molecules and support upcoming first-In-human dose and longer-term dosing studies in healthy, patient, or special populations.

    LEARN MORE
  • Safety Pharmacology Studies

    SAFETY PHARMACOLOGY STUDIES (CNS, cardiovascular, respiratory)

    SAFETY PHARMACOLOGY STUDIES (CNS, cardiovascular, respiratory)

    Our experts assess the impact of your therapeutic entity on vital organ systems before first-in-human trials. To support your IND-enabling, we can assist you in identifying and minimizing potential risks earlier, so that you can advance your best molecule through preclinical development and beyond.

    LEARN MORE
  • Immunotoxicology and Immunology Studies

    IMMUNOTOXICOLOGY/ IMMUNOLOGY STUDIES

    IMMUNOTOXICOLOGY/ IMMUNOLOGY STUDIES

    Our immunotoxicology testing investigates how chemicals, drugs, or environmental factors can impact the immune system, cause adverse events, and potentially lead to immune-related disorders. These studies help us ensure the safety of drugs and chemicals by identifying their potential risks to the immune system. Our scientists also develop and validate immunological assays.

    LEARN MORE

Commitment to Animal Welfare in Preclinical Research

We prioritize animal welfare in our preclinical research. Our staff are extensively trained in laboratory animal care, focusing on humane treatment and environmental enrichment. Adhering to strict regulatory guidelines, we ensure compassion and sensitivity in every aspect of our research practices.

Our Commitment to Animal Welfare

Compassion means putting that animal's needs before your own. And compassionate animal care means leaving everything from the outside world behind and being present in that moment with that animal to meet that animal's needs in a moment-by-moment basis. As part of our mission we've developed a leading animal welfare program that not only complies with the highest regulatory requirements and guidelines, but more than that, our program was founded on a culture of compassion, respect, and integrity. It is these principles that drive our program and also the core belief that the work we do with these animals is a privilege. When our clients ask what distinguishes our CRO and the animal welfare program from anyone else's, I tell them it's two things. Number one, people. And number two, the compassion that they bring to their job to do it right. To ensure the animals well-being and safety is a top priority, every employee engages in rigorous and ongoing training regardless of their role. Each employee's commitment begins at onboarding when they sign an animal welfare contract and pledge for C.A.R.E. Our C.A.R.E program: Compassion, Alternatives, Reduction, and Enrichment is one that's very unique to this business. Our C.A.R.E program does not just embody one particular month during the year but it's every day, of every week, of every month. We have people in the organization that concentrate purely on the behavior and the well-being of the animals. Our veterinary team is available to offer 24 hour observations. We have a dedicated team who works with each species to provide appropriate animal training designed to reduce stress. Additionally, our behavior and enrichment team ensures the psychological well-being of each species by providing environmental enrichment through positive human interactions, appropriate housing conditions and through stimulus and activities. Over 90% of our animals are socially housed and we also offer EU housing. We have a standing animal welfare meeting that brings all operational groups together on a weekly basis, and a diverse IACUC team who ensures all research is conducted with the highest scientific, humane, and ethical principles. The quality of animal care that we provide today determines the quality of medicine that we put forth tomorrow. We... are Altasciences.

Advanced Preclinical Research Facilities

Altasciences' state-of-the-art preclinical research facilities, spanning over 585,000 square feet in strategically placed locations throughout North America, provide an ideal environment for comprehensive safety testing and bioanalysis in rodent and non-rodent species. Conducting over 700 safety studies annually, we offer a full range of in vivo GLP and non-GLP safety assessments for your drug substances. Our facilities are equipped to support pivotal toxicology, safety pharmacology, and laboratory solutions for small and large molecules, ensuring your submissions meet global regulatory requirements.

Explore Our Facilities

Related Resources

Consult this issue of The Altascientist to learn about key considerations when planning your preclinical assessment for IND submission.

Read this issue of The Altascientist to learn about nonclinical cell and gene therapy development and how to maximize translational opportunities to FIH trials.

Consult our fact sheet on Miniature Swine to see if they are a viable non-rodent option for your small or large molecule studies.



Preclinical Services: FAQs

Which preclinical drug development studies do you offer?

Our preclinical CRO services include single dose/acute, dose range finding, sub-chronic dosing, chronic dosing, carcinogenicity, safety pharmacology, toxicology, and PK/PD studies. Most safety assessment studies needed for your CTA/IND-enabling programs can be conducted at one of our many preclinical sites.

Do you offer supporting services for preclinical drug development?

We offer scientific, regulatory and strategic guidance, protocol development, project management, analytical chemistry, bioanalysis for small and large molecules, toxicokinetics, anatomic pathology, clinical pathology, reporting, SEND, and archiving of your preclinical research samples.

How do you ensure the 3RS are applied when conducting preclinical drug development studies?

We have an innovative and robust animal welfare program that ensures that the physical and mental safety of our animal models is at the forefront of our activities, and that the 3Rs are rigorously applied. All employees sign a pledge to honor the animals in our care. 

For a more in-depth look at how we ensure animals are treated humanely and with care, view our animal welfare and preclinical research videos.
 

Do you work with both rodents and non-rodents for nonclinical drug development programs?

Yes, we work with both small and large animal models for all your preclinical research needs.

Our preclinical research facilities consist of 585,000 square feet of purpose-built space in four strategically placed locations throughout North America. They are equipped with animal rooms that include European housing, and we are constantly working to develop innovative low-stress methods of working with our research animals.
 

Do you offer preclinical to clinical integrated development programs?

Yes, we do. When you partner with us for an integrated end-to-end program, we design clinical trials using the preclinical data to our best advantage. We ensure a constant flow of communication and open collaboration, so that you only have to Tell Us Once™, and we will take care of the rest.

Whether you choose our preclinical research services or the entire drug development solution from lead candidate selection to clinical proof-of-concept (and beyond), we are here to help.
 

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