Life Sciences
Risk Regulatory Compliance Risk Regulatory Compliance

Regulatory Affairs, Quality and Patient Safety

Our team combines considerable experience in industry and at FDA with current regulatory and technical knowledge to provide U.S and international clients with expert guidance for the most demanding projects focused on Pharmaceuticals, Biotech, Medical Devices, IVDs, Biologics, Combination Products, Companion Diagnostics, and Connected / Mobile Health products. Guidehouse professionals offer unparalleled expertise supporting all phases of the product life cycle, from product concept and early planning to post-market compliance. Our solutions include:

  • Regulatory strategy and FDA & OUS agency submission preparation 
  • Quality system design and update
  • Regulatory compliance and quality system remediation
  • Interim management
  • M&A due diligence, transaction support, and integration
  • Expert witness
  • Complex data analytics and customized technology solutions

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