COMBINATION PRODUCTS AND MEDICAL DEVICE CONSULTING LTD.

Regulatory Innovation. Strategic Execution. Business Impact

Expert consulting for pharmaceutical and medical device organisations navigating the regulatory and technical complexities of combination products.

Regulatory Strategy

FDA Interaction

Notified Body Opinion package

Design Controls

Design Reviews

Design History File

Technical Leadership and Strategy

Medical Device Regulations

Standards Compliance

Device Master Record

Remediation

Bridging Package

Change Management

Regulatory Strategy FDA Interaction Notified Body Opinion package Design Controls Design Reviews Design History File Technical Leadership and Strategy Medical Device Regulations Standards Compliance Device Master Record Remediation Bridging Package Change Management

Combination Products and Medical Devices Consulting Ltd. (CPMD) partners with executive, regulatory, and technical leaders to navigate the complexity of combination products and medical devices with clarity, rigour, and integrity. Operating through a three-pillar model - Regulatory Strategy & Innovation, Quality & Technical Excellence, Commercial Readiness & Lifecycle Management - we develop clear, defensible regulatory strategies, enable aligned cross-functional decision-making, and strengthen leadership capability across regulatory, quality, technical and commercial functions. Our work supports efficient approvals, reduces regulatory and operational risk, and ensures the compliant delivery of safe, effective products that ultimately reach patients with confidence and integrity. Learn more about our Three-Pillar Operating Model in the Approach section.

By providing expert guidance across the full product lifecycle, CPMD Consulting Ltd. accelerates approvals, mitigates risk, and protects long-term investment across global markets. As a trusted and independent advisor, we take the time to understand each organisation’s unique challenges, delivering tailored, pragmatic solutions—from strategic planning through to implementation.

Grounded in strong ethical principles, CPMD Consulting Ltd. delivers integrity-driven support that strengthens organisational capability, enables decisive leadership, and translates strategic intent into disciplined, real-world execution. Through our work, we help advance patient access to safe, effective, and compliant medical technologies worldwide.