Integrated Submission

Full-range support from planning to post-filing

Your product’s best endorsement is a well-executed dossier of evidence. Our cross-functional team can help you develop a complete filing strategy that brings together the right data for a compelling dossier that improves chances for seamless approvals across different countries and regulatory markets.

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Global and Local Safety and Risk Management Experience

Quintiles supported the development of the AHRQ user's guide on Comparative Effectiveness Research.

Help regulatory authorities make the right decision

You know your product’s story and have confidence in the data. And you have no doubt the product will make a difference in the lives of patients worldwide. But you need to ensure that regulatory officials have all the information they need to come to the same conclusion, even after a lengthy and complex registration process.

A comprehensive approach helps tell your product’s strongest story

No product’s story is one-dimensional, and its dossier shouldn’t be, either. Our integrated team of medical writers, biostatisticians, regulatory specialists and subject matter experts work together to develop a thorough filing plan that includes all of the data needed for proper analyzing, interpretation and packaging. From early engagement and planning to post-filing support, we work with you across global markets to increase efficiency, decrease risks to quality and achieve a successful dossier.

The power of possibilities

Time, energy and money have been invested in your product. Launching it on time brings the most value for a better return on your investment. Quintiles’ integrated approach to product registration and filing clears the path to approval and success.

Related Services

Between March 2011 and March 2012, Quintiles processed 267K+ safety cases at an on-time rate of 99%. Additionally, 59K+ cases were reported to regulatory authorities with 99.8% on-time compliance.
Quintiles has engaged with more than 2,500 hospitals participating in the AHA's Get with The Guidelines program.
Quintiles has provided clinical services to more than 475 real-world and late phase programs since 2011.