EVALUATION AND TESTING SERVICES (ETS) FOR VACCINES AND OTHER BIOLOGICS FOR INFECTIOUS DISEASES

Summary

This contract provides comprehensive product development and testing services for new vaccine candidates and biologics targeting infectious diseases, from early feasibility to regulatory submission.

What they want

The Evaluation and Testing Services (ETS) contract offers a range of product development services. These services span from initial feasibility studies through all necessary activities required for the submission of Biologic License Application (BLA) and/or Investigational New Drug (IND) applications. The primary goal is to facilitate the development and introduction of new vaccine candidates and biologics, regulated by CBER, specifically against potential agents of bioterrorism and emerging and re-emerging infectious diseases.

Deliverables

Activities required for Biologic License Application (BLA) submission
Activities required for Investigational New Drug (IND) application submission