Hi, I'm Denise! I specialize in helping companies like yours navigate the complex regulatory landscape with ease. Here’s how I can assist:
My Services:
- 510(k) Submissions: Comprehensive writing, editing, and templates.
- Q-Sub Preparation: Crafting detailed and effective submissions.
- IDE Support: Clear, concise writing and editing.
- SOP Development: Custom-tailored and compliant processes.
- Audit Preparation
- Recall Support
- Regulatory Affairs Training: Equip your team with essential skills.
...and much more!
Why Choose a Regulatory Affairs Consultant?
- Cost-Efficiency: Avoid the $100k–$175k/year cost of a full-time specialist.
- Flexibility: Engage me for specific aspects of your project only.
- Interim Solutions: Fill the gap while you search for the perfect FTE candidate.