Combination Products

services-star

Combination products demand coordinated expertise across drugs, biologics, medical devices, manufacturing, and regulatory affairs. GSAP brings these disciplines together to help organizations reduce complexity, align development activities, and navigate global regulatory pathways from concept through commercialization.

Diagram

How We Support Combination Product Companies

 

  • Regulatory Strategy & Product Classification
    PMOA assessment, product classification, FDA Request for Designation (RFD) support, Office of Combination Products interactions, global regulatory pathway assessments, and regulatory gap analyses.
  • Quality Systems & Regulatory Compliance
    FDA 21 CFR Part 4 compliance, integration of drug and device quality system requirements, quality system implementation, and global regulatory gap assessments.
  • Risk Management & Validation
    Risk management, interface management between drug and device constituents, process validation, cleaning validation, and contamination control strategies.
  • Manufacturing Transfer & Supplier Oversight
    Design transfer, manufacturing transfer, supplier qualification, oversight of critical component manufacturers, and quality agreement development.
  • Inspection Readiness & Quality Remediation
    Inspection readiness, deviation investigations, complaint management, CAPA programs, Data Integrity assessments, and remediation activities.
  • Training & Organizational Readiness
    Training programs for Quality, Manufacturing, Engineering, and Regulatory Affairs teams.