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Regulatory Affairs

Helping ensure global regulatory compliance – every step of the way

When you partner with us, our world-class, cross-functional teams will help you deliver more efficient submissions across your product’s lifecycle, using advanced workflow automation systems integrated into Regulatory Information Management (RIM) systems.

Doctor and woman

7,000+ product registrations serviced in 150+ countries since 2015

Leveraging years of experience including former regulatory agency staff from FDA, EMA, and other major agencies.

Helping you achieve faster, more efficient submissions from start to finish

Our comprehensive global expertise can help you confidently interact with Regulatory Authorities around the world, and package and present all the information necessary to allow Regulatory Authorities to make the right decision.

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Maximize the commercial value of your products

regulatory affairs body image 2We understand the current industry challenges for post-approval regulatory affairs, including the pressures of pricing, emerging market regulations, focus on data and the increased emphasis on risk assessments. Our team can help you:

  • Create a new model reflecting changing industry dynamics
  • Re-deploy your headcount to important development projects while we serve as variable assets
  • Improve the working relationships with key departments, such as pharmacovigilance

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Combining global reach with integrated people, processes and technology

Our people, processes, and technology are the foundation of everything we do for you. Our people can provide their expertise wherever and whenever you need it. Our processes are focused on providing you with operational excellence and synergies. And our technology is underpinned by data and analytics capabilities; our advanced workflow automation systems can provide greater transparency to help you identify bottlenecks and mitigate risks to avoid costly mistakes.

With a global regulatory team that includes professionals in several countries, gaining regulatory approval is a more predictable outcome. Contact our team at GlobalRegulatoryRFP@quintilesims.com to discuss how we can work together.

White Paper Jan 08, 2015
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