The regulatory process starts with a well thought out strategy. After a thorough review, we work with you to help develop a strategic regulatory plan tailored to your specific product. This regulatory plan will take your business objectives and factors about markets, countries, and regulatory agencies into account.
Our regulatory team has extensive experience interacting with the FDA and the knowledge we have gained help our client's submission processes go smoothly, thus minimizing time to market. Our regulatory affairs and quality assurance consulting includes services in the following areas:
- Strategic planning and development
- Regulatory body liaison, including FDA Agent representation
- Preparation and representation at FDA advisory panels and regulatory agency meetings
- Preparation for and participation in FDA-sponsor meetings such as Pre IDE
- FDA Form 483 or Warning Letter response
- Global product strategy
- Labeling and ad/promo review
- Interpretation of standards and guidelines
- Assistance in successful Quality System procedure design
- Risk Management (based on ISO 14971:2007)
- Compliance Q&A
- Protocol and Informed Consent Development
- Post-market surveillance
- 510(k) Premarket Notifications (Traditional, Special or Abbreviated)
- PMA Applications, Supplements and Reports
- FDA Establishment Registration and Device Listing
- 513(g) (medical device classification)
- Medical Device Reporting (MDR) review and support
- Humanitarian Device Exemption (HDE)
- Health Canada Medical Device and Establishment License Applications
- Clinical Report Preparation
- IDE Submissions and Associated Reports
- IRB and Ethics Committee Submissions