Expert Support for Your IND/CTA Requirements
Partnering with Altasciences for your IND/CTA needs will ensure that your application to regulatory agencies moves forward as smoothly and efficiently as possible. To reach your milestones on time, we recommend setting up a meeting to consult with us at least one year before your targeted IND/CTA submission date to allow for program design and ordering of research animals.
Altasciences can help you compile the key information necessary to approve your application request, including:
- Animal pharmacology and toxicology studies to assess safety;
- Manufacturing processes to ensure consistent batches of the study drug;
- Clinical protocols and investigator information to assess tolerance and risk.
For a more detailed overview of the regulatory planning process, consult our Preclinical Assessment Planning Guide.
You may also be interested in the following:
- Webinar: Navigating the Challenges of Early Drug Development
- Fact Sheets:
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services.
Webinar—De-Risking Peripheral Neuropathies With Nerve Conduction
Altasciences' Proactive Drug Development Solution: Biologics
Development of a Flow Cytometry Phospho-STAT5 Assay in Nonhuman Primate T Cells
Strategies for Reducing the Number of Animals in Toxicity Testing: A Comparative Approach for Rodent and Large Animal Studies
Gene Therapy Utilizing Adeno-Associated Viral (AAV) Vectors: Historical Data Review to Characterize Common Challenges and Identify Opportunities for Refinement
Comparison of Toxicology Assessment Baseline Data Collected Using Two Restraint Methods in Nonhuman Primates: Restraint Chair/Pole and Collar vs. Procedure Cage
Downsized Sinclair™ vs. Göttingen™ Minipigs Similarities and Differences of Toxicological Reference Range Data in Preclinical Safety Studies
Ocular Imaging and Microscopic Analysis of Focal Chorioretinal Defects in Rabbits
Validation of an SC5b-9 Commercial Kit for Preclinical Biomarker Analysis