Regulatory Affairs
Regulatory affairs strategy is one of the biggest hurdles in running clinical trials. Increased trial complexity, regulation, and the need for multi-venue approval are driving this trend. Biorasi’s regulatory team has worked with regulatory agencies around the globe, including the most difficult venues.
Navigating Complex Trials to Approvals
Removing Obstacles on the Road to Approval
Staying in compliance with regulatory guidance and requirements for clinical trials can be challenging. Achieving product regulatory approval is even more so. The complexity of seeking multi-venue regulatory approvals has led the industry to agree that regulatory affairs strategy is one of the biggest hurdles in running clinical trials.
Biorasi’s regulatory staff has experience in negotiating complex legal environments around the world. We can get our trial moving anywhere you need it to be.
Our global experience gives Biorasi the insight to proactively suggest regulatory venues and strategies that can dramatically increase program ROI.
Biorasi’s clinical trial regulatory staff don’t just react to problems. They proactively identify potential pain points and create strategies to avoid or mitigate problems.
Biorasi’s office-based workplace allows regulatory staff to work closely with PMs and Clinical teams to create synergies not found at other CROs.
Regulatory guidance and mandates change often and are not always clear cut nor consistent across geographies. Biorasi has the experience and the agility to help you stay ahead of regulatory challenges around the world.
Beyond Just Monitoring
Biorasi’s team has worked with regulatory agencies in the most difficult venues across the globe. We have developed a comprehensive approach where clinical development programs and individual studies are designed from the ground up to address the regulators’ requirements to achieve the highest chance for your trial’s ultimate acceptance and success. So whether your goal is to get a novel product approved by a single regulatory authority, such as the FDA, or to get global approval by FDA, EMA and others in one program, our expert team will guide you through the evolving regulatory maze on your journey to market.
Our Regulatory services include:
- Regulatory consulting
- IMPD compilation
- Preparation and submission of regulatory submission packages
- Communication and follow up with competent authorities
- Study registration on ClinicalTrials, EudraCT, and other trial databases
- Import/export management
- Site ethics approvals
Let us be part of your important work to find a solution to design your trial.
