Assisting you to develop pharmaceutical products for your chosen regulatory pathway.
Our team of scientists and regulatory professionals 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.
You will have access to a dedicated project management team with leading scientific consultants across all workstreams, backed by Broughton’s laboratory operations. New product development is broken down into three simple phases
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:
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.
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.
From basic questions to complex compliance inquiries, we're here to help! Contact us today.