Case Study

Expert IND Publishing Support For An Understaffed Regulatory Team

GettyImages-1411632179 clinical team

A clinical-stage biotechnology company that develops novel therapies to treat patients with blood cancers and autoimmune diseases was seeking a regulatory publishing partner. The company was interested in end-to-end publishing capabilities from a vendor requiring minimal guidance and supervision. The rapidly growing biotech’s lean regulatory affairs team needed expert external support to produce high-quality submission outputs in varying formats while adhering to timelines and complying with health authority requirements.

Access the case study to discover how the company was able to successfully file its IND submissions and complete CSR publishing tasks, in addition to creating a synchronized team capable of accommodating ad hoc publishing requests.

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