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Benefits of RegDesk Peer
Tap into the largest network of world class regulatory and reimbursement consultants on demand
Obtain opinions in 3 simple steps
Provide your objectives
Select the market(s)
Obtain validated insights
Assessment of why PMDA (Japan) may request Clinical Trial Data in some situations versus Clinical Investigation Data for the same product
A large medical device manufacturer, faced one frustrating challenge while seeking approval for antimicrobial central venous catheters and antimicrobial dressings in Japan. There seemed to be an inconsistency in the Pharmaceuticals and Medical Devices Agency.
Frequently Asked Questions
Q: What is RegDesk Peer?
A: RegDesk Peer is an expert-sourced and peer-reviewed method of getting in-depth insights about the regulatory status of your product(s) or for assessing the business impact(s) related to changes made to the product(s).
Q: How can I use RegDesk Peer?
A: To use RegDesk Peer, you will need to provide your objective, the specific questions you would like to have answered and the markets for which you are seeking the answers.
Q: How many expert opinions will I have access to?
A: For most most markets and situations, we will utilize 3 on-the-ground, product specific experts for your project.
Q: Will I need to select and filter the experts?
A: RegDesk Peer works seamlessly once you submit your questions; RegDesk sources and selects the best possible experts. You see the finished product in the form a report.
Q: How long will it take to get my answers?
A: Once we have all the information required from you, 3 weeks.
Q: Will I have information about the qualifications of the experts?
A: In the interest of full transparency, RegDesk Peer provides you the names and professional backgrounds of all the experts that worked on your project.
Q: How experienced are your experts?
A: On average, RegDesk Peer experts have between 10 and 15 years of either regulatory, market access or reimbursement experience.
Q: Can I speak with these experts?
A: Upon report submission, if the client feels a phone call would best suit their need for further answers, RegDesk can schedule a half hour phone call directly with the individual experts.