In an area as important as regulatory affairs, you need expertise to avoid costly mistakes and to reduce delays.
We can provide:
- Regulatory Assessments; Class determination and details on the most efficient pathway to product clearance
- Risk Assessments/Hazard Analyses
- Clinical study design, protocols, data analysis and reports
- Design verification and validation reports
- Product Labeling
- Marketing/Technical Support information
- Writing and support of all types of regulatory submissions
- 513(g) – Class determination
- RFD – Request for Designation of Combination Products
- Q-subs – Presubmissions5
- 510(k) and De Novo – Premarket Notification
- MAF – Device Master Files
- PMA – Pre-Market Approval
- IDE – Investigational Device Exemptions (for clinical trial leading to PMA)
- HDE – Humanitarian Device Exemption
- BLA – Biologics License Application
- CMC Sections – Chemistry, Manufacturing, Controls sections for IDE and PMA
- Clinical Evaluation Reports, Technical Files, Design Dossiers for Notified Bodies