Regulatory Strategy and Compliance
Regardless of your industry, a sound regulatory strategy provides a foundation for successful healthcare innovation. This is particularly relevant for the established and emerging diagnostics companies that are developing highly sophisticated molecular diagnostics products, facing increased regulatory oversight of ASRs and IVDMIAs, or dealing with evolving regulation of home-brew tests and CLIA labs.
In each case, Beaufort is here to help you develop and implement customized regulatory strategies designed to optimize the development of your in-vitro and molecular diagnostics products.
Our regulatory services for diagnostic companies include:
- Regulatory strategy development
- Predicate device identification
- Device classification
- Protocol and study design design development
- Statistical Analysis Plan
- Representation before regulatory bodies
- Preparation for and conduct of meetings with regulatory bodies
- Pre-IDE meeting preparation (scheduling, information package development, presentation assistance, and FDA mediation)
- Statistical programming and data analysis
- Preparation of pre-market submissions: IDE, PMA, and 510(k)
- Device Master Files
- Labeling and advertising review
- Continuing FDA liaison
- Warning Letter resolution
- EU experience
- Regulatory training
Review case studies regarding Beaufort’s regulatory strategy and compliance services for diagnostics companies.
