Our New Product Development (NPD) service helps clients accelerate their product from prototype to regulatory approval.

How Product Development can help

Our team of scientists and regulatory professionals with expertise in developing next generation nicotine delivery systems and medical devices work within an entrepreneurial and agile framework to deliver rapid success to clients across the industry.

Working in close partnership with clients, our energized and passionate team thrive to deliver high quality solutions through scientific excellence to accelerate safer nicotine-delivery products to market, advancing a smoke-free future.

What does Product Development involve?

You will have access to a dedicated project management team with leading scientific consultants across all workstreams, backed by Broughton’s GLP standard laboratory operations. New product development is broken down into three simple phases:

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Phase I - Target Product Profile Development

The Initiation stage focuses on understanding the vision of your product, product design and regulatory pathway. This is an important stage in determining the design input requirements in the form of a design matrix, which is then used as a reference point to ensure development studies are appropriate to realise your vision. The key areas within the product vision stage are:

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Phase II - New Product Development Design 

Our scientific strategy consultants review all the information collected in phase I to develop the appropriate study designs for your product. Our subject matter experts, who are supported by a dedicated Project Manager, have years of industry experience and are up to date with the latest regulatory landscapes appropriate for your product.

The Broughton team are ready to provide full-service guidance and support for your regulatory submission.  

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Phase III - NPD Delivery to POC and Development Feasibility Assessment

Following agreement with the Client, phase III delivers the necessary activities required to demonstrate POC for the product. Following the completion of the activities, results will be compiled into a Client report which describes whether proof of concept has been demonstrated and whether the product is therefore designed aligned with regulatory requirements.

A full breakdown of the project plan is provided indicating timings, associated costs and risks that are necessary to take the product through full development to the desired regulatory submission goal.

Demonstration of POC for your product will enable you to secure further investment for full development and could also be used to demonstrate the device design and development acceptability as part of an ongoing regulatory submission strategy or CE mark application process.


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Scientific Strategy and Consultancy

Our scientific strategy encompasses all the information collected through the key phases above to develop the appropriate study designs for your product, supported by dedicated Project Management. Our subject matter experts have years of industry experience and are up to date with the latest NGP regulatory landscape.

The Broughton team are ready to provide full-service guidance and support for your regulatory submission.  

A fully integrated approach 

Our team of experts, with their collective years of experience in the NGP sector, including regulatory expertise, registered toxicologists, dedicated development and validation scientists, and dedicated experienced analytical team, are focused purely on this industry and have the level of understanding required to design your study with you to maximize the efficiency and value of the testing.

New Product Development (NPD)

Resources

Leaflet

Overview of our full-service PMTA compliance solution, from planning through to compilation and submission.

Guide

Understand what’s involved in a PMTA and how the recommendations relate to your ENDS business.

Leaflet

Download our leaflet for an overview of our comprehensive services to support the NGPS industry from regulatory submission to maintaining compliance.