Altasciences is an integrated early-phase drug development partner supporting biopharmaceutical companies from lead candidate selection through clinical proof of concept. With preclinical, clinical pharmacology, bioanalysis, formulation, manufacturing, analytical, and research support services under one organization, Altasciences helps sponsors move programs forward with fewer handoffs and stronger continuity across development.

Overview

Altasciences is built for companies that need speed, scientific depth, and a coordinated path through early drug development. Their model brings together preclinical safety testing, Phase I and Phase II clinical research, bioanalytical services, formulation development, manufacturing, and analytical support, allowing sponsors to work with a single partner across critical development milestones.

For biotech and pharmaceutical teams preparing for IND-enabling studies, first-in-human trials, or early clinical proof-of-concept work, Altasciences offers a flexible outsourcing path designed to reduce complexity and keep programs moving.

Accreditations & Compliance

Altasciences supports regulated and non-regulated development work across preclinical, clinical, bioanalytical, and manufacturing environments. Their preclinical facilities support GLP and non-GLP studies, with site-level accreditations and registrations that include AAALAC accreditation, USDA registration, OLAW or PHS assurance, BSL-2 capabilities, DEA registrations at applicable sites, and CDC registration for specific facility operations.

Their operations are structured to support global regulatory expectations for IND-enabling toxicology, safety pharmacology, bioanalysis, clinical pharmacology, and early-phase clinical development.

Core Services

Altasciences provides preclinical safety testing for small molecules, biologics, animal health products, agrochemicals, and biocides, including in vivo GLP and non-GLP studies in rodent and non-rodent species. Their capabilities include toxicology, safety pharmacology, PK/TK support, bioanalysis, and IND-enabling study programs.

Their clinical services support early-phase clinical development, including first-in-human studies, Phase I, Phase II, clinical pharmacology, protocol development, monitoring, data management, biostatistics, medical writing, and regulatory support.

Altasciences also offers bioanalytical services for preclinical through Phase IV programs, with small and large molecule capabilities, LC-MS/MS, ligand binding, assay development, assay transfer, and integrated laboratory support across U.S. and Canadian sites.

Additional services include formulation development, manufacturing and analytical services, research support, program management, medical writing, biostatistics, and data management for sponsors looking to consolidate more of their early development work with one provider.

Technology & Expertise

Altasciences combines preclinical, clinical, bioanalytical, and manufacturing expertise to support smoother transitions between development stages. Their integrated model is especially valuable for sponsors that want to move from preclinical safety work into clinical pharmacology without rebuilding the project team or transferring knowledge across multiple vendors.

Their facilities support a wide range of study types, including small molecule, biologic, monoclonal antibody, gene therapy, oligonucleotide, ADC, ocular, CNS, dermal, juvenile toxicology, and non-rodent surgery programs.

With purpose-built preclinical sites, clinical pharmacology units, bioanalytical laboratories, and manufacturing support, Altasciences is positioned for sponsors that need an early-development partner capable of handling complex, regulated, and milestone-driven programs.

Best Fit Projects

Altasciences is a strong fit for sponsors preparing for IND-enabling studies, GLP toxicology, safety pharmacology, PK/TK analysis, bioanalytical method development, first-in-human studies, Phase I and Phase II clinical research, early clinical proof-of-concept, formulation development, and integrated preclinical-to-clinical development programs.

They are especially well suited for teams that want one partner across multiple parts of the development pathway instead of managing separate CROs, bioanalytical labs, and manufacturing vendors.

Why Work With Altasciences Through CROaccess

Through CROaccess, sponsors can evaluate Altasciences for complex early-phase development programs, compare fit against other qualified CROs, and streamline proposal collection, documentation, communication, and project tracking in one place.

Altasciences brings the infrastructure of an established early-phase CRO/CDMO, while CROaccess helps sponsors manage the outsourcing process with more visibility, organization, and speed.