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.

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

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

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

Pharmacology

Our pharmacological testing predicts biological effects of new therapeutic entities, supported by our extensive bioanalysis capabilities.

Pharmacokinetics/ Pharmacodynamics

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.

Pivotal Toxicology (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.

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.

Immunotoxicology/ Immununology

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.

Commitment To Animal Welfare In Preclinical Research

At Altasciences, 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.

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.