Case Study
Expertise in RNA TherapiesLearn how Veristat has supported some of our Biotech Sponsors in advancing their RNA therapeutics.
Case Study
The Power of Publishing for an Efficient NDA Submission ProcessRelieving the Strain of Regulatory Publishing Throughout the Product Lifecycle
Case Study
Supporting a Sponsor from SPA Rejection to BLA SubmissionSuccessful Engagement with FDA to Achieve SPA Approval for Running the Phase III Pivotal Trial
Case Study
New Tumor Evaluation ModalityUsing intratumor RECIST (itRECIST) criteria to measure effectiveness of cancer therapeutics
Case Study
Approvals for an Ultra-Rare Hematologic MalignancyRegulatory Submission Strategy and Novel Efficacy Endpoint for Treatment of an Ultra-Rare and ...
Case Study
First Gene Therapy Approved in EuropeVeristat was brought in to create and manage a full development program for a gene therapy for a ...
Case Study
Writing Multiple Marketing Applications At The Same TimeA mid-size pharmaceutical company and its development partner, a small biotechnology company ...
Case Study
Stem Cell Therapy for Stroke PatientsA client engaged the Veristat team in a Phase II study of intracerebral stem cell injection in ...
Case Study
Complex Trial for a Rare Pediatric Gene TherapyA clinical-stage biotechnology start-up asked Veristat to run a new European trial of their complex ...