Finding innovative regulatory solutions since 2015
The regulatory success of a medical product depends on a clear story line substantiated by pre-market data and a thoughtful strategy to grow with the product into the post-market lifecycle. At BlueThread, we pride ourselves in expert, first principal communication strategies which results in quicker agency review timelines and product approvals. Let us do the talking, so you can focus on what you do best, innovation and developing the world’s next great technologies.
Areas of Expertise
Drug/Device Combination Products
Navigating the complex regulatory environment of global drug/device combination product regulations.
Pre-market testing strategies
Testing strategy consultation to ensure complete and concise submission packages which facilitate smooth and quick agency review and approval.
Post-market product regulatory compliance maintenance
Establishing Quality System processes to ensure ongoing compliance, annual regulatory reporting tasks, and regulatory strategies for post-approval change management.
Get in Touch
Submit an inquiry to get started with your regulatory solutions today.