PRECLINICAL DRUG DEVELOPMENT
With over 25 years of experience conducting safety assessment, Altasciences offers a full range of GLP services in both rodents and non-rodents to thoroughly assess the safety profile of your molecules. Working as an extension of your team, we help you expedite your research goals, ensuring that your safety assessment program provides quality data for key decision making.
Altasciences’ preclinical drug development solutions include IND/CTA-enabling toxicology, safety pharmacology, and laboratory services, for both small and large molecules. Our team of preclinical research scientists and technicians has experience in the conduct of safety testing in both rodents and non-rodents. Our purpose-built facility is AAALAC-accredited, USDA-registered, with OLAW Assurance and BSL-2 certification, and is fully compliant with EMA, FDA, OECD, and GLP requirements.
Under one operational structure, and with a dedicated single Program Manager for each project, Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions to offer an integrated/synchronized approach to CRO and CDMO services. From lead candidate selection to clinical Phase II, we integrate bioanalytical assay development and validation, nonclinical safety evaluation, formulation development, clinic-ready manufacturing, on-demand clinical pharmacy, and clinical testing to proof of concept.
With Altasciences as your partner, you can plan for Phase I/II studies at the outset, ensuring a smooth transition from preclinical to first-in-human (FIH) studies.
Consult our fact sheets and watch our video:
PRECLINICAL DRUG DEVELOPMENT STUDY TYPES
We offer a full range of IND/CTA-enabling studies and BLA/NDA-enabling toxicology and bioanalytical services, providing powerful tools and rigorous solutions for preclinical drug development as you evaluate therapeutic candidates, advance lead compounds toward first-in-human trials, and support ongoing clinical development. We have expertise with many routes of administration.
- Lead optimization
- General toxicology (acute, sub-chronic, chronic)
- Safety pharmacology (CNS, cardiovascular, respiratory)
- Immunotoxicology and immune function
- Pharmacokinetics (PK) and Pharmacodynamics (PD)
- Dose range finding/maximum tolerated dose
We have experience with and are equipped to conduct preclinical studies in a wide array of species.
Rat | Mouse | Dog | NHP | Rabbit | Guinea Pig | Minipig | Swine
COMPREHENSIVE FULL-SERVICE OFFERING
- Webinar: Comparison of US FDA and Health Canada CTA submission to Support First-in-Human Phase I presented by Julie Forget, Director of Toxicology and Paul Sidney, Senior Director, Compliance and Regulatory Affairs
- Webinar: SEND Progress Update presented by Courtney Turnbaugh, SEND Supervisor
- Webinar: Navigating the abuse potential evaluation of CNS-active drugs for EU and US submissions presented by Dr. Beatrice Setnik, Chief Scientific Officer and Andy Mead, Head of Drug Abuse and Substance Use Disorders, Sygnature Discovery
- Podcast: Altasciences Scientific Experts Discuss Safety Pharmacology presented by Julie Forget, Director of Toxicology and Jean-Christophe, Associate Scientific Director.
- Podcast: Altasciences’ Commitment to the 3Rs presented by Dr. Christina Cruzen, Attending Veterinarian and Chief Animal Welfare Officer and Shayna Halverson, Manager, Quality Assurance
- Podcast: Science, 3Rs, and Animal Welfare with Dr. Megan R. LaFollette from 3RNA, presented by Dr. Christina Cruzen, Attending Veterinarian and Chief Animal Welfare Officer
- Podcast: Consultant Series ― Chat with Dr. John Atkinson, Founder of Atkinson Toxicology Consulting