IND SERVICES
Prevalere’s IND services offer early stage biotechnology companies, that lack the internal resources to conduct product development, with a cost-effective alternative. Prevalere draws on the extensive product development expertise of our core team of consultants to assist in the development of biologics. Prevalere has successfully provided expert guidance for IND applications which have met FDA approval.
Prevalere’s IND Services Include:
• Defining strategic decision points
• Designing and managing animal studies that
are likely to be required to satisfy safety
requirements prior to Phase I clinical studies
• Preparing proposals for non-clinical
pharmacology studies
• Performing GLP inspections of non-clinical
sites conducting studies
• Developing and validating bioanalytical
methods to support non-clinical studies
• Performing PK/PD analysis of data to define
dosing strategy for the clinic
• Reviewing draft and final study reports
generated by study facilities
• Preparing relevant sections of regulatory
submissions (i.e., IND, NDA, BLA)
