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Quintiles Consulting

Contact: Phil Johnson, Senior Director, Quality & Compliance Services 
Specialty:  New and Existing Drugs/OTC, Devices and Diagnostics, Biologics/Biotechnology

OVERVIEW

Quintiles (NYSE: Q), a Fortune 500 company, is the world’s largest provider of biopharmaceutical development and commercial outsourcing services.  Leveraging our global reach and local knowledge and expertise, we offer a specialized Global Regulatory, Compliance and Quality Advisory Services team who partner with customers to optimize their regulatory and quality performance. Our experienced advisors can provide the dedicated, knowledgeable and flexible support you may need, to meet the requirements for new and existing products. Through an unmatched combination of industry leaders and former Notified Body, FDA and EMA officials, our advisors provide a wide range of services, including:

  • Regulatory strategy – integrated solutions based on global and local expertise in 60+ countries
  • GCP, GLP, GMP and cGMP compliance and risk mitigation
  • Quality system design, optimization and remediation
  • Third party auditing services for contract manufacturers and suppliers
  • Regulatory compliance remediation – a track record of successful resolution of warning letters and establishing foundations for sustained compliance
  • Mock Notified Body audits and mock FDA inspections
  • Clinical Evaluation Reports, following MEDDEV 2.7.1 guidance
  • CE Technical file compilation, review and adaptation to a STED structure for international use
  • Development and implementation of procedures for vigilance and post-market surveillance
  • Advice on labelling requirements, language and translation
  • Updating services on local and global regulatory developments

DIFFERENTIATORS

With a network of more than 33,000 employees conducting business in more than 100 countries, we helped develop or commercialize all of 2014’s top 75 best-selling drugs on the market. Quintiles delivers breakthrough thinking built on decades of industry experience. Quintiles has worked in virtually every therapeutic area, from development through commercialization to post-market, with biotechnology, pharmaceutical and device companies of all sizes. We’re thinkers and doers who leverage connected insights across our organization to deliver services that improve your probability of success.

Years in business: 30+
 

   949-202-8429
   949-272-3490
   This email address is being protected from spambots. You need JavaScript enabled to view it.
   www.quintiles.com

 

 

 

 


Twitter Account: @Quintiles 

 

 

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