Services
REGULATORY
Tailored to the unique requirements across global markets, including the United States, Europe (Notified Body Opinion), South Korea, Malaysia, etc.
✅ Development of Regulatory Strategy aligned with business objectives
✅ Identification and application of relevant international standards
✅ Preparation of bridging briefing packages
✅ Expert guidance on authoring regulatory documentation
✅ Provision of submission templates to streamline dossier development
✅ Authoring of regulatory submissions for various jurisdictions
✅ Leadership in Health Authority interactions and meeting preparation
✅ Pre-submission checklists and mock audits to ensure readiness
✅ Regulatory due diligence for acquisitions, partnerships, or portfolio expansion
QUALITY OR TECHNICAL
Specialized support in technical documentation and quality system development to ensure compliance with global regulatory standards and seamless integration with your internal processes.
✅ Expert guidance on Design History File (DHF) structure and content
✅ Provision of DHF templates tailored to product type and regulatory requirements
✅ Authoring of DHFs in alignment with your Quality Management System (QMS)
✅ Development and enhancement of Quality Management Systems to meet ISO 13485 and FDA 21 CFR Part 4 requirements
COMMERCIAL
Strengthening commercial readiness and lifecycle management of products through targeted technical and strategic services.
✅ Guidance and authoring of Device Master Records (DMR) to ensure documentation integrity and regulatory alignment
✅ Design History File (DHF) gap analysis with actionable strategies to address deficiencies
✅ Root cause analysis and problem-solving to resolve technical and compliance challenges
✅ Management of post-market changes, including documentation updates and regulatory impact assessments
TRAINING
Targeted training programs designed to build cross-functional competence across the full lifecycle of Combination Products and Medical Devices. Our sessions are tailored to the regulatory and technical requirements of your target markets and delivered with practical, hands-on insight.
✅ Regulatory training for Combination Products and Medical Devices, customized to jurisdictional requirements and team roles
✅ Development-phase training to support cross-functional alignment and product readiness
✅ Post-market maintenance training focused on compliance, change management, and lifecycle documentation
COACHING
Personalized 1:1 coaching for professionals working with Combination Products and Medical Devices. Our sessions provide strategic and technical guidance to help individuals build confidence, deepen expertise, and achieve success in their roles.