The regulatory process starts with a well thought out strategy. After a thorough review, we work with our clients 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 helps our clients' 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
- US and International 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
- Labeling and promotions review
- Interpretation of standards and guidelines
- Assistance in Quality System design
- Risk Management (based on ISO 14971:2007)
- Compliance Q&A
- Protocol and Informed Consent Development
- IRB/Ethics Committee Submissions
- 510(k) Premarket Notifications (Traditional, Special or Abbreviated)
- PMA Applications, Supplements and Reports
- FDA Establishment Registration and Device Listings
- 513(g) Medical Device Classification Requests
- Medical Device Reporting (MDR) Submissions
- Humanitarian Device Exemptions (HDE) Submissions
- Health Canada Medical Device and Establishment License Applications
- Clinical Reports
- IDE Submissions and Associated Reports
- EU Technical Files and Design Dossiers