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Quality Systems & QMS Integration

  • Design and align quality systems across drug and device functions.
  • Implementation of 21 CFR Part 4 and QMSR at new "Green Field Sites"
  • Alignment to ISO 13485 within pharma environments
  • Cross-functional harmonization across development, quality, regulatory, and manufacturing
  • Document hierarchy and QMS architecture

Combination Product Development & Strategy

  • Define and align development strategies across drug and device systems.
  • Combination product classification and regulatory pathway (21 CFR Part 3)
  • Integration of Design Controls (21 CFR 820 / QMSR) with Pharma QbD (ICH Q8–Q12)
  • Development planning aligned to FDA and global expectations
  • Gap assessments for IND, NDA, BLA, and device submissions

Supplier Quality & External Manufacturing Oversight

  • Establish scalable oversight models for CMOs, device suppliers, and test labs.
  • Supplier qualification and onboarding (risk-based per ICH Q9)
  • Material qualification and change management, including extractables and leachables considerations
  • Production Part Approval Process (PPAP) adapted for medical devices and combination products
  • Quality agreements, including authoring, negotiation, and remediation
  • Supplier performance monitoring, scorecards, and governance models

Auditing & Inspection Readiness

  • Internal and external audits aligned to ISO 19011
  • Supplier, CMO, and test lab audits
  • Mock FDA inspection readiness (21 CFR Parts 210, 211, 820, and Part 4)
  • CAPA evaluation and effectiveness aligned to ICH Q10 principles

Design Controls & Lifecycle Management

  • Design controls implementation (21 CFR 820.30 / QMSR)
  • Risk management aligned to ISO 14971
  • Design transfer and technology transfer
  • Change management and lifecycle control (ICH Q12)

Technical Quality & Manufacturing Strategy

  • Control strategy development (ICH Q8 and ICH Q11)
  • Process validation strategy, including process performance qualification and continued process verification
  • Industrialization and scale-up
  • Deviation, investigation, and root cause support

Combination Product Import & Distribution

  • Importation and distribution requirements for combination products under 21 CFR Part 4
  • Risk management aligned to ISO 14971
  • Design transfer and technology transfer
  • Change management and lifecycle control (ICH Q12)

Training & Advisory

  • Combination product, QMSR, and regulatory training
  • Audit and CAPA capability building
  • Fractional quality leadership and advisory support

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