Resources

Please find the following complimentary resources below.

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PMTA developments expected in 2022

Dr. Nveed Chaudhary, Chief Scientific and Regulatory Officer

Opportunities for ENDS companies in 2022

Dr. Nveed Chaudhary, Chief Scientific and Regulatory Officer

The time is now for ENDS 2022

Dr. Nveed Chaudhary, Chief Scientific and Regulatory Officer

Challenges for ENDS companies in 2022

Dr. Nveed Chaudhary, Chief Scientific and Regulatory Officer

Why studies should be considered in a wider context

Paul Hardman, Head of Scientific Affairs

Which studies help us to understand unintended user appeal?

Dr. Nveed Chaudhary, Chief Regulatory Officer

How is consumer acceptance determined?

Dr. Nveed Chaudhary, Chief Regulatory Officer

What is a puffing regime?

Chris Allen, Chief Scientific Officer

Why is it important to justify the choice of puffing regime for a product ?

Chris Allen, Chief Scientific Officer

What are the different types of puffing regimes?

Chris Allen, Chief Scientific Officer

What's the key role of toxicology when assessing the safety of chemicals inhaled from ENDS?

Yvonne Wilding, Director Product Safety and Compliance

What post-Brexit changes can we expect to regulations for ENDS sold in Britain ?

Yvonne Wilding, Director Product Safety and Compliance

How can toxicology studies support new product development ?

Yvonne Wilding, Director Product Safety and Compliance

How does toxicology enable the safeguarding of human health ?

Yvonne Wilding, Director Product Safety and Compliance

What are the immediate changes to regulations for ENDS sold in Britain ?

Yvonne Wilding, Director Product Safety and Compliance

Have you received a deficiency letter?

Do you have the team in place ready for this stage? If not, now is the time to act. We can help.

Supplementary data to support your PMTA application

If you are anticipating a letter and require supplementary data to support your PMTA, now is the time to act.

See Through The Smoke

Series 1: Talking ENDS

Pre-market tobacco product applications

Benjamin Green, Senior Project Manager, explains the Premarket Tobacco Product Application (PMTA) – open the door to the US market for ENDS companies.

The differences in ENDS regulations

Yvonne Wilding, Director Product Safety and Compliance, explains the differences in ENDS regulations.

The similarities in ENDS regulations

Yvonne Wilding, Director Product Safety and Compliance, explains the similarities in ENDS regulations.

Computational prediction models in toxicology

Learn more about computational prediction models in toxicology.

Airways Cell Model for ENDS Aerosol exposure

Dr. Emmanuel Minet, Principal Scientist, explains 3D Airways Cell Model for ENDS Aerosol exposure.

Introduction to ToxHQ

Learn more about how Broughton can help by clicking on the button below.

See Through The Smoke

Series 2: Talking ENDS

Risk continuum

Paul Hardman, Head of Scientific Affairs

Understanding total harm reduction for next generation nicotine delivery products

Dr. Nveed Chaudhary, Chief Regulatory Officer.

Demonstrating reduced risk

Dr. Nveed Chaudhary, Chief Regulatory Officer.

The importance of clinical and behavioral research for next generation products (NGP) assessment

Dr. Nveed Chaudhary, Chief Regulatory Officer.

Accelerating Life-Enhancing Pharmaceutical Products To Market

Learn how our scientific experience and technical capabilities can help accelerate your pharmaceutical drug or device development project across different stages.

Regulatory Digest

Subscribe to our regulatory digest for the latest industry updates.

Technical Due Diligence: Product Development Services

Learn how we can help reduce costs and increase speed by enabling the right decision at key moments to avoid costly mistakes, delays, or reworks later in the project.

Case Study Scenario: The Fast Track

Learn more about how our Technical Due Diligence Fast Track service can help your business identify any weaknesses or gaps in the early stages of product development to better inform decision-making and investment choices.

Case Study Scenario: The Deep Dive

Learn more about how our Technical Due Diligence Deep Dive service can offer an in-depth investigation of a product’s development status to ensure informed decision-making and better investment choices.

Pharmaceutical Marketing Authorization

This infographic outlines the routes to a Pharmaceutical Marketing Authorization in the UK.

Analytical Development Services

Broughton is a leading GMP analytical services provider. Learn more about what we offer.

A Guide To PMTA For NGP Businesses

Increase the value of your business with a successful PMTA with this guide for NGP businesses.

Best Practices Guide - Volume 1. QC Data Analysis

Learn the best statistical tools for QC Data Analysis and examples of how they can be applied in practice.

A Guide To TPD & TRPR

Get the overview for the Tobacco Products Directive and Tobacco-Related Products Regulations.

FDA Final Rule Snapshot

Download Broughton’s guide on the FDA final rule.

A Guide To Toxicology Risk Assessments

Understand the process for ENDS products.

TRPR (TPD) Vs MAA Comparison

See the key differences between TPD and Medicinal Product authorization for your ENDS products.

Extractables & Leachables

Learn more about Broughton’s ENDS dedicated extractables and leachables service.

How Do You Select A Laboratory To Partner With

Learn how to choose a laboratory that is the right fit.

Out of Specification Investigation Checklist

Get helpful tips on areas to consider when conducting out of specification investigations.

Drug Development Pathway

Download a free infographic of our analytical services supporting drug development pathway.

Test Method Transfer Checklist

Download our free test method transfer checklist today to help you with a compliant transfer process.

Case Study: Reduce Downtime In Production

Download this case study to learn how Broughton helped a client reduce downtime in production.

Generic Molecules List

At Broughton we have successfully transferred over 140 generic molecules and the list continues to expand. Download a copy today.

Quality Control Services

Selecting the right laboratory for quality control services is important to ensure you maintain customer satisfaction.

Techniques and Capabilities

Broughton is a full analytical service provider with state-of-the-art facilities. View our full list of in-house techniques and capabilities.

NGP Service Guide

Learn more about how we help companies of all sizes through the product lifecycle stages, from concept innovation, product realization, and regulatory submission to post marketing surveillance.

Medicinal Cannabis and CBD services

At Broughton we have spent the last 10 years working with UK, EU, and US regulators in relation to tobacco regulations being retrospectively applied to next generation nicotine products such as vapes and e-cigarettes.

A Summary of the Legal Status and Regulatory Pathways to Market for Cannabinoid Products in the UK Market

At Broughton we can help summarises the regulatory pathways available for cannabinoid products and the legal requirements for each potential market route.

Strategic Insights to reignite PMTA confidence

Download strategic insights to reignite PMTA confidence, reduce costs and protect timelines while continuing to innovate.

Next Generation Nicotine Product Services Flier

Learn more about our next-generation nicotine product services.

Contact us

From basic questions to complex compliance inquiries, we're here to help! Contact us today.