Case Study, Medical and Scientific Writing

Client: Biopharma Startup Client

Case Study, Medical and Scientific Writing

A New Biopharmaceutical Company Requires Assistance in Preparation for Regulatory Submissions

 

Situation

A startup biopharmaceutical company asked Pearl for assistance in preparing scientific reports and manuscripts for regulatory submission, and in support of an upcoming product approval and launch. The client also required help composing several pharmacokinetics publications, abstracts, and posters.

Solution

Pearl provided a team of medical writers, biostatisticians, and clinical and scientific experts to work collaboratively with the client. Pearl led all medical writing activities and a cross-functional team to manage the project, including efforts to secure references and raw data. At the project’s conclusion, Pearl helped the company produce a total of 16 high-quality, submission and publication-ready reports and manuscripts.

 
 

Result

The client met their project deadlines early, received regulatory approval, and successfully published in peer-reviewed journals. They were extremely pleased with the quality of the writing and have worked with Pearl on many subsequent projects.


 

Pearl Pathways is a comprehensive life science product development services company. Every day we strive to provide our customers top quality service, unyielding ethics, and efficient services through our team of experts. Pearl Pathways supports biopharmaceutical, medical device, and diagnostic companies as well as life science service providers with clinical, regulatory, and quality compliance needs. Our full-service central IRB supports all aspects of human research.

 
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