Drug & Medical Device Regulatory Consulting
Our highly experienced regulatory consultants bring a wealth of knowledge of the most up-to-date regulations, directives, laws, policies, and guidelines. It is our job to sort through the details, interpret guidelines, and recommend the right course of action for your organization.
Many small and startup companies often cannot afford having their own regulatory departments. SRC is positioned to act as your Regulatory department on an “as needed” basis with significant cost savings. In serving your needs we provide value to your organization to avoid costly and sometimes irreversible mistakes.
Our regulatory consulting includes but is not limited to:
- Regulatory strategic planning from design to market (e.g., Fast Track, orphan drug, drug vs. cosmetic)
- Product Classification Review (Devices, Drugs, Combination products)
- FDA meeting management for key Milestone meetings with Regulatory Agencies (e.g., Pre-IND, Pre-IDE, End Phase 2)
- Medical devices regulatory support for 510(k), IDE and PMA
- Labeling & advertising review
- Risk Management Plans
- OTC drugs: Rx-to-OTC switch, Time and Extent Application
- US Agent status for non-US Companies
- Compliance Crisis Management
- Experienced medical writing staff
