Health
Life sciences consulting

Life Sciences

Life Sciences

Regulatory Quality Patient Safety

In the complex regulatory environment of today’s pharmaceutical, biotech, medical device, and diagnostics industries, companies and their counsel face an increasing number of regulatory issues that have the potential for significant competitive economic and reputational impact. Our portfolio of regulatory services across the life sciences spectrum includes:

  • Regulatory Pathway Planning, Analysis & Strategy
    • EU MDD to MDR transition
    • Global Regulatory Development Strategy and pathway development for Pharma/ Biotech/Combination/Device products
  • Design Controls and Product Realization
    •  Software as a Medical Device (SaMD)
    • Artificial Intelligence and Machine Learning (AI/ML)
    • Combination Products
  • Regulatory Agency submissions
    • United States NDA, ANDA, PMA, 510(k), BLA submissions
    • EMA: MAA, CTA, ODD, PIP, Scientific Advice
    • PSMF, Pharmacovigilance system and associated Quality System design and implementation
  • Quality Management System Implementation
    • ISO 13485, 9001, etc.
    • GAP analysis, Planning, Strategy, Training 
  • Inspection Readiness Audits
    • Mock FDA, EMA, MHRA and Notified Body audits
  • Nonconformance remediation
    • FDA Warning Letters
    • FDA 483
    • Notified body audits
  • Software Implementation
    • Design and execution of RIMS (regulatory information management systems) and eQMS (electronic Quality Management System) 
  • Litigation support for clients and their counsel
  • M&A Due Diligence and post-deal integration
  • Regulatory compliance with applicable product regulations, guidance, and international standards
  • Supplier management for low, medium, and high risk providers

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