Regulatory Services
Navigate the complex regulatory landscape with our comprehensive Regulatory Services. From pre-market application support to technical leadership, we guide you through every step of the submission process, ensuring that your regulatory strategy aligns with your business objectives and market goals.
Pre-Market Application Support
Develop comprehensive regulatory strategies and manage pre-submission meetings to align your product development with regulatory expectations.
Application Development
Draft, compile, and manage technical documentation and submissions for regulatory applications, including EUMDR and FDA (eSTAR).
Application Project Management
Oversee project management to ensure timely and effective regulatory submissions, coordinating efforts across cross-functional teams.
Technical Leadership
Provide ongoing technical leadership in regulatory matters, manage responses to Notified Body feedback, and offer training to your team.
Sol MedTech 