REGULATORY SUBMISSION CAPABILITIES INCLUDE:
Let Fang Consulting be your guide through the domestic and international regulatory maze. We know that you want to launch a safe and compliant product into the global market as efficiently as possible.
- Pre-market notification (FDA 510(k)'s)
- Investigational Device Exemptions (pre-IDE and IDE)
- Pre-market Approval (PMA) applications
- Product Development Protocols (PDP)
- Post-market surveillance protocols
- Establishment registration and device listing
- Medical Device Reporting (MDR) and complaint handling
- CE marking
- Vigilance reporting
- Standards and guidelines
- FDA regulatory agency meetings
- Storage and Distribution
GET MORE FROM YOUR REGULATORY SUBMISSIONS
Regulatory submissions are central to gaining market approval. Every regulatory body requires them and each agency has its own requirements. Creating a regulatory submission that will move through the approval process quickly and efficiently requires much more than compiling and presenting the data. It also requires careful organization and adherence to the content and format requirements set by the regulating agencies. Additionally, on-going communication with regulatory agency staff members, as well as presentations at regulatory agency meetings, are critical to success.
Our staff prides themselves in their ability to create clean and concise regulatory submissions for major agencies worldwide. This includes the Food and Drug Administration (US), European Notified Bodies (EU), the Health Protection Branch (Canada), the Ministry of Health, Labor and Welfare (Japan), and the Therapeutic Goods Administration (Australia).
By preparing QA/RA data and submissions right the first time, our Regulatory Affairs consultants can cut down on the number and extent of deficiency requests from a regulatory agency, which can lead to quicker approvals of your medical device and fewer demands on your employees to locate missing information and formulate answers to questions.
Effective communication with regulatory officials is also one of our strong points. Our track record is based on longstanding relationships with regulatory bodies, such as the FDA, that have been built on trust. Finally, we can help your company prepare for any regulatory agency meetings through practice question and answer sessions and other techniques.