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RegDeskTM is the developer of a cutting-edge, A.I.-powered intelligence software system that provides medical device companies with competitive regulatory insights.

The Challenge

Getting medical products to market is an extremely arduous process that every medical device and pharmaceutical company, big and small, is struggling with. In fact, obtaining regulatory approval in foreign markets is one of the biggest hurdles these companies must clear when attempting to expand globally. Companies may spend several months gathering regulatory intelligence and preparing registration applications before submitting their dossiers to local health authorities.

Globally, over 60% of applications submitted to local health agencies are rejected for reasons unrelated to the safety and effectiveness of the product.

Misinterpreting local regulations and guidelines and proceeding with erroneous intelligence are oftentimes the main causes of rejection. The failure to clench approval from health authorities results in significant delays in product launch, which can hurt patients’ access to life-saving treatments and cost product manufacturers millions of dollars in lost revenue and massive slices of market share.

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Our Solution

RegDesk ™ is the developer of an A.I.-powered regulatory intelligence solution that covers over 100 markets globally. Our software suite incorporates machine learning, powerful visualization tools, and crowd-sourcing to deliver comprehensive, actionable regulatory insights to our clients, making it a complete regulatory intelligence solution for companies that are ready to expand internationally and penetrate foreign markets.

Key Product Features

• Offers instant access to comprehensive regulatory intelligence for over 100 markets worldwide
• Identifies required registration dossier components for the product and market in question
• Predicts which markets clients should penetrate next as they prepare applications for their target markets
• Leverages a network of 4,000+ compliance experts to provide clients with multiple validated answers to their most critical questions
• Keeps track of the world’s ever-evolving regulatory landscape so that clients don’t have to
• Delivers product-specific alerts so that clients can see the changes that are most relevant to their case

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RegDesk ™ delivers instant access to the most current and most competitive regulatory intelligence, streamlines the registration application process, expedites time-to-market, and pushes companies to awaken their latent market potential.

Clients can save upwards of 4 months of time when they choose to work with RegDesk ™ over traditional regulatory consulting firms. Decreasing time-to-market increases internal cost savings, leads to faster revenue generation for our clients, and advances patient access in countries all over the world.

RegDesk Priya Bhutani, Founder & CEO
Priya Bhutani, Founder & CEO
RegDesk -Jixian
Jixian Wang, CTO
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3401 Market Street, Suite 200
Philadelphia, PA 19104
desk@regdesk.co | www.regdesk.co