Global Expansion Strategy
Global medical device market access requires navigating regulatory systems that vary significantly in structure, requirements, and timelines. Expansion strategies must balance market potential against regulatory investment.
RegOps provides market access expertise across established and emerging device markets worldwide. We help you prioritize expansion targets, develop efficient registration strategies, and execute submissions through local regulatory pathways. Our approach minimizes redundant effort by leveraging existing regulatory documentation and approval references where permitted, while ensuring market-specific requirements are fully addressed.
Our Capabilities
Comprehensive support for entering new global markets.
Strategic analysis of potential markets considering regulatory complexity, timelines, market size, and local requirements. We help you focus resources where they generate greatest return.
Detailed evaluation of registration requirements for target markets including submission formats, testing, and local representation. We map pathways and identify documentation needs.
Adaptation of existing regulatory documentation for international submissions, including Technical File conversions, form completion, and local language documentation.
Management of relationships with local regulatory agents, Authorized Representatives, and in-market partners. We coordinate activities and ensure regulatory alignment.
Leveraging of FDA clearance, CE marking, and other reference approvals in markets with reliance pathways. We identify opportunities to accelerate registration.
Ongoing support for maintaining registrations including renewals, annual filings, variation submissions, and vigilance. We ensure continued market access.
The RegOps Advantage
We design registration approaches that leverage existing documentation, minimizing new work for each market entry.
Global Network
We maintain relationships with consultants and local representatives across target markets, enabling effective execution.
Efficient Strategies
We leverage existing documentation and approval references to minimize new work required for each market entry.
Realistic Planning
We provide accurate timeline and cost estimates, enabling informed business decisions about expansion priorities.
Ongoing Partnership
We support ongoing compliance, renewals, and expansion into additional markets as your business grows.