Regulatory Affairs

Stay current in every location

When you partner with Quintiles, our world-class, cross-functional teams will deliver more efficient submissions across your product’s lifecycle.

Doctor and woman

1,900 eCTD submissions and 100% have passed technical validation

Quintiles has published and prepared over 700 non-eCTD electronic submissions and 1900+ eCTD submissions to the EU, US and Canada, with 100% of documents passing technical validation.

Access global scale with local knowledge

Our Global Regulatory Affairs team at Quintiles includes a network of professionals across the globe dedicated to keeping you aligned with the latest local regulatory developments.
Regulatory requirements are continually evolving and vary from country to country. You need to stay alert to increase your chances for approval, ensure your submission runs smoothly and make certain development proceeds uninterrupted, thus improving the probability of success for your product. 

Let us stand guard so you can stay vigilant

With a global regulatory team that includes professionals in several countries, gaining regulatory approval is a more predictable outcome. 

Our services include: 

  • Marketing applications. Global and regional MAA/NDA/BLA submissions; authoring and publishing (MAA/NDA/BLA, IND and other dossiers); regulatory project management of dossiers; dossier gap analyses; CMC, clinical and nonclinical; OMP and ODD. 
  • Regulatory maintenance/Lifecycle support. License extensions, maintenance and renewals; compliance; due diligence; regulatory writing support; clinical and commercial linkage; portfolio optimization. 
  • Regulatory strategic advice. Clinical and regulatory program strategy; global regulatory roadmaps capturing regional considerations; scientific advice: pre-submission, EOP2, CHMP, national agencies; pediatric plans in EU and US and multi-country filing strategy; combination products, biomarkers and targeted therapies. 

Watch our recent webinar: Value Vigilance: A Transformative Approach to Managing Safety and Regulatory for Established Products

Proof in marketplace

Quintiles’ comprehensive global expertise can help you confidently interact with regulatory affairs authorities around the world and package and present all the information necessary to allow regulatory authorities to make the right decision. 

  • 100% of approximately 1,900 eCTD submissions to the EU, US and Canada have passed technical validation. 
  • 65+ INDs and over 17 million pages published between 1999 and 2015. (all document types, e.g., eNDA/amendments).
  • Over 5000 maintenance/lifecycle submissions prepared between 1999 and 2015.
  • 70% of our regulatory professionals hold advanced degrees, with an average of more than 16 years of experience.

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Quintiles Blog: The days of paper are over

By: Mike Hagan, Senior Director, Regulatory Affairs  |  September 9, 2016

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