Regulatory
Let Fang Consulting be your guide through the domestic and international regulatory maze. We know that you want to launch a safe and complaint product into the global market as efficiently as possible.

SECURE GLOBAL REGULATORY APPROVALS WITH LESS EFFORT
Reaching beyond the US market can expand the possibilities for your business. However, a global product launch requires global regulatory approvals. If the prospect of running a clinical trial across multiple time zones, conducting an investigator meeting in a foreign language or translating regulatory submissions seems daunting, your concerns are justified. Global approvals can be time consuming, puzzling and resource intensive. But they can be manageable with the proper strategy and planning. The US regulatory approval process may even go more smoothly as a result.

We can help you with global approvals by factoring in the global issues up front. Well-traveled Fang Consulting professionals can design clinical trials that leverage data obtained in multiple countries. Our staff can help identify countries most amenable to your product due to historical, social or economic factors among others. After the clinical is underway, we are also prepared to negotiate with international health authorities about your particular product. This expertise extends beyond the product approval to post launch medical product reporting requirements.

You may also gain valuable information from the global regulatory process that will help make the US process go more smoothly. These global insights can help you in preparation of domestic labeling and marketing communications materials. The result is a more successful product launch, not a more cumbersome one.

GLOBAL REGULATORY CAPABILITIES INCLUDE

• Strategic international regulatory and clinical planning
• Global regulatory authority negotiations
• European representative identification and selection
• Export requirement definition
• Foreign language and labeling requirement analysis
• Post approval vigilance and reporting

WORLDWIDE REGULATORY STRATEGIES & SUBMISSION

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 professionals pride themselves on their ability to create clean and concise regulatory submissions for major agencies worldwide. This includes the Food and Drug Administration (US), European Notified Bodies, the Health Protection Branch (Canada), the Ministry of Health (Japan) and the Therapeutic Goods Administration (Australia).

By preparing a submission right the first time, we can cut down on the number and extent of deficiency requests from a regulatory agency. That can lead to quicker approvals 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 officials that have been built on trust. Finally, we can help your company prepare for regulatory agency meetings through practice question and answer sessions and other techniques.

REGULATORY SUBMISSION CAPABILITIES INCLUDE:

• Pre-market notification (510 (k))
• Investigational Device Exemptions (pre-IDE and IDE)
• Pre-market Approval (PMA) applications
• Product Development Protocols (PDP)
• Humanitarian Device Exemptions (HDE)
• Post-market surveillance protocols
• Labeling
• Establishment registration and device listing
• Medical Device Reporting (MDR) and complaint handling
• CE marking
• Vigilance reporting
• Export/import certificates and registrations
• Standards and guidelines
• FDA Panel/regulatory agency meetings