Austin Preclinical Consulting LLC provides expertise in all aspects of preclinical drug development from early lead optimization through NDA or BLA. We can assist in strategic development, design, implementation, management and oversight of preclinical, IND enabling toxicology programs as well as ADME and efficacy work associated with small molecule, protein-based large molecule, antibody, vaccine, and nucleotide-based drug development. Furthermore, we can support your post-IND preclinical requirements in support of phase 2 and 3 clinical trials (e.g. peri-post natal reproductive toxicology, chronic, and carcinogenicity studies) to help complete your new drug application or biologic license application.
Our skill extends to efficacy models in indications such as cancer, metabolic, inflammatory, neurodegenerative and immunologic diseases and we can provide complete assistance in the development and implementation of these studies.
We can also support you with developing the nonclinical portions of your regulatory filings in support of INDs, IMPDs, BLAS, IBs and other technical regulatory documents.
We also possess significant experience in evaluation of drug development opportunities for companies involved in due diligence and licensing activities (acquisition or out-licensing) and can help you weigh the advantages and disadvantages of potential partnering programs.
For those companies operating as virtual biotech businesses, you can leverage our extensive knowledge of international GLP compliance and regulations as your acting head of preclinical development. We can assist in the selection, audit, and oversight of CRO's for your externally contracted studies with the knowledge that your critical preclinical work is smoothly and efficiently managed.