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Case Study

The Power of Publishing for an Efficient NDA Submission Process

Relieving the Strain of Regulatory Publishing Throughout the Product Lifecycle

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Case Study

Supporting a Sponsor from SPA Rejection to BLA Submission

Successful Engagement with FDA to Achieve SPA Approval for Running the Phase III Pivotal Trial

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Case Study

New Tumor Evaluation Modality

Using intratumor RECIST (itRECIST) criteria to measure effectiveness of cancer therapeutics

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Case Study

Approvals for an Ultra-Rare Hematologic Malignancy

Regulatory Submission Strategy and Novel Efficacy Endpoint for Treatment of an Ultra-Rare and ...

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Case Study

First Gene Therapy Approved in Europe

Veristat was brought in to create and manage a full development program for a gene therapy for a ...

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Case Study

Writing Multiple Marketing Applications At The Same Time

A mid-size pharmaceutical company and its development partner, a small biotechnology company ...

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Case Study

Stem Cell Therapy for Stroke Patients

A client engaged the Veristat team in a Phase II study of intracerebral stem cell injection in ...

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Case Study

Complex Trial for a Rare Pediatric Gene Therapy

A clinical-stage biotechnology start-up asked Veristat to run a new European trial of their complex ...

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Case Study

Full Service Support for A Gene Therapy Trial

A clinical-stage biotechnology start-up asked Veristat to run complex US and EU trials of their ...

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