FDA regulatory strategy is slow…
but we make it RAPID™
Use RAPID across all four categories of medical product innovations.
While regulatory affairs professionals and consultants tend to specialize in one category of product innovation, RAPID works for any medical product in the four major categories.
Medical Device
Drug Product
Biologic Product
Combination Product
Use RAPID for novel products or modifications to existing products.
Novel Products
Working with a brand-new innovation that has not yet gotten to market? RAPID works for any phase of novel product development.
Modifications
Working with an existing product that is planning modification? RAPID works for any modification to existing products.
Boost your productivity without adding any additional staff.
A significant amount of time is currently involved in the manual process of pathway identification. Often, with limited resources and constraints on time, RA departments are forced to pick the highest priority tasks, given their resource constraints, hire additional staff, or bring in consultants to boost their output. RAPID allows departments to easily increase their existing capacity without any additional hiring or consulting services.
RAPID stands for Regulatory Affairs Pathway ID. With RAPID, confidently gain assurance that you have identified and evaluated the best regulatory pathways.
In the status quo, regulatory affairs departments and professionals must rely on the work and expertise of experienced staff or consultants to identify pathways to FDA product clearance or approval, often uncertain about the efficacy or availability of alternative pathways. With RAPID, users can quickly identify alternative pathways allowing them to focus on making sure they pursue the most promising regulatory strategy with confidence.
Quickly identify the impacts of product modifications and different designations on regulatory strategy in minutes …not months
One of the most time-consuming tasks a regulatory affairs professional or team can be assigned to is pathway identification for a product that has an evolving feature set or multiple potential designations for evaluation. Often, regulatory professionals can spend weeks or even months, updating and reassessing their strategies during this process. RAPID allows users to quickly identify promising pathways to FDA approval and clearance at any stage of development, for any number of changing features or designations.
FAQs
How do I know that RAPID works?
That’s simple. Take a regulatory strategy and pathway you have already identified for a product and run RAPID for that product. You will be given pathways to evaluate along relevant FDA guidance documentation. In our experience, the only “downside” of this process is that you may realize there was a better pathway to pursue!
How is RAPID different from other RA software?
RAPID is the only software that allows users to perform pathway identification for FDA clearance and approval. Additionally, RAPID works for novel products and modifications to existing products, whether they are medical devices, pharmaceuticals, biologics, or combination products.
How much time does RAPID really save?
RAPID does not “replace” a regulatory affairs professional. But it may eliminate days of work every time an RA professional needs to perform pathway identification. For many departments, this could mean the difference between hiring more staff or simply doing more with less. It’s also a fantastic tool for due diligence.
Does RAPID work for other Health Authorities?
At the current time, RAPID is only suitable for use for products seeking FDA approval or clearance in the premarket or postmarket environment. It is our intention to add other Health Authorities as options as the product grows in popularity to meet the broader needs of globally marketed medical products.
Sign up for the RAPID beta test. Join the movement.
Collaboration with accelerators, university research teams, and proof-of-concept testing with regulatory affairs professionals has allowed for RAPID to provide value for many regulatory affairs industry professionals.
If you would like the opportunity for your department to try RAPID, then please register using the form below.
Questions/professional inquiries? Reach us at contact@rapidregulatory.com