Pharmaceutical, biotechnology and medical device companies have been presented with extraordinary regulatory and quality compliance challenges, as a result of consolidation, restructuring and economic uncertainty. Without the right attention, these challenges can weaken quality systems and processes, erode domain and critical thinking expertise, and cause core quality principles to be neglected – leaving companies vulnerable to compliance lapses and enforcement action. These issues are only exacerbated with the disparate systems that result from outsourcing, mergers and acquisitions.

Quintiles Advisory Services helps you with all aspects of global quality and regulatory compliance, including developing regulatory strategies, conducting compliance audits and gap analyses, conducting mock inspections, ensuring good clinical, laboratory and manufacturing practices, and preparing responses to FDA 483 citations and warning letters. Our approach ultimately transforms and enhances business operations by: 

  • Integrating key components including the analysis and auditing of current operations
  • Developing a proactive quality and compliance strategy
  • Creating corrective and preventative action plans (CAPA). 
We also tailor quality training programs and support organizational change management in order to drive overall compliance sustainability.

Our Thinking

Lax data integrity rules are putting your company at risk
Reduce risk in your supply chain