When faced with an aggressive timeline for our IND submission, BioData Solutions stepped in and delivered beyond expectations. In just two and a half weeks, they drafted the entire bioanalytical section for our cell and gene therapy product — a process that normally takes months. It involved managing and verifying complex datasets across pharmacokinetic, pharmacology, and toxicology modules, while accurately describing over 20 diverse bioanalytical methods spanning from LC-MS/MS to qPCR platforms to support biomarkers to immunogenicity assay. Their ability to harmonize data from multiple sources and deliver audit-ready content under such pressure was remarkable. Without their expertise and team-based approach, meeting this deadline would not have been impossible.
