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Industry Insight and Expert Knowledge to Help your Business Succeed

Staying on top of regulatory changes, new technical innovations, and industry-disrupting competitors has never been harder. With so much information available, how do you ensure you have the insight you need to drive your business forward and seize opportunities before the competition?

 

Our regulatory and scientific experts are here to help you stay up to speed with new trends and research. Let them share their expertise and insight so you can focus on building your business.

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Explore our Resource Library

Browse our resource library to get more insight into the latest industry trends and a better understanding of the right regulatory framework to choose for your innovation or new product. Learn how our scientific and regulatory experts can help create competitive advantage and new business opportunities through their insight and expertise.

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Brochures & Service Guides

Cannabis-Services
Cannabinoids

Cannabis Services

Enhancing the positive reputation of cannabis by accelerating safe, efficacious, and high-quality cannabis products to a regulated market. Learn more about our cannabis services. 

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ICH-Product-Stability-Storage-and-Analysis-Brochure
Pharmaceutical Nicotine Cannabinoids

ICH Product Stability Storage and Analysis Brochure

With over 60,000 liters of in-house ICH stability storage capacity, supported by a team of highly qualified scientists and GMP-accredited laboratory testing facilities, we have approximately 250 live studies in progress and offer a full range of stability services to help bring your product to market or ensure its ongoing compliance requirements.

 

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PMTA-Guide-For-NGP-businesses
Nicotine

PMTA Guide For NGP businesses

At Broughton, our consultants have deep industry knowledge across all the elements required for a PMTA. We guide you through and generate the required data, to ensure that FDA finds your applications strong and compelling.

 

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A-Guide-To-TPD-and-TRP
Nicotine

A Guide To TPD and TRP

An overview of the Tobacco Products Directive and Tobacco-Related Products Regulations. Get the straightforward answers you’re looking for when it comes to TPD and TRPR analysis.

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TRPR-(TPD)-Vs-MAA-Comparison-Chart
Nicotine

TRPR (TPD) Vs MAA Comparison Chart

Looking to take your ENDS products to new markets? Compare the differences and get the pros and cons between products with EU Tobacco Products Directive (TPD) notification and products with an EU medicinal product license in our free download.

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Next-Generation-Nicotine-Products-Service-Guide
Nicotine

Next Generation Nicotine Products Service Guide

We help companies of all sizes through the product lifecycle stages, from concept innovation, product realization, and regulatory submission to post marketing surveillance. 

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A-Guide-To-Pharmaceutical-Marketing-Authorization-in-the-UK
Pharmaceutical

A Guide To Pharmaceutical Marketing Authorization in the UK

The MHRA is now a stand-alone body issuing national authorizations only. This infographic outlines the routes to a Pharmaceutical Marketing Authorization in the UK.

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Pharmaceutical-Services---Extractables-and-Leachables
Pharmaceutical Nicotine Cannabinoids

Pharmaceutical Services - Extractables and Leachables

The evaluation of extractables and leachables (E&L) is an essential component of the pharmaceutical development process.

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Toxicology-Advice-and-Consultancy-Services
Pharmaceutical Nicotine Cannabinoids

Toxicology Advice and Consultancy Services

Our team of in-house toxicologists reviews and evaluates toxicological data on a wide range of chemicals to produce independent expert opinions on risk assessment. We then advise on the strategies to mitigate or reduce those risks to protect corporate reputation and public health.

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Pharma-Inhalation-Services
Pharmaceutical

Pharma Inhalation Services

Developing and commercializing new inhaled drug products, requires huge energy and deep scientific understanding. This level of resource and subject matter expertise can be difficult to maintain inside your business, and that is where we can help.

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Medicinal-Cannabis-and-CBD-Services
Cannabinoids

Medicinal Cannabis and CBD Services

Learn more about our UK and EU Novel Food Application scientific consultancy and analytical testing support.

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Technical-Due-Diligence:-Product-Realization-Services
Pharmaceutical Nicotine Cannabinoids

Technical Due Diligence: Product Realization Services

Our product development and regulatory experts can help you meet expectations at key milestones in your product development project to better inform decision making and investment choices.

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Quality-Policy
Pharmaceutical Nicotine Cannabinoids

Quality Policy

We believe that the sectors we work within expect a continually improving service where we constantly strive to improve processes and Quality.

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How-to-Spot-an-Illicit-Vape
Nicotine

How to Spot an Illicit Vape

Learn about six easy-to-spot packaging violations that  could indicate a vape is illicit and shouldn't be on sale in the UK and EU.

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Ensuring-Safety-in-the-Booming-CBD-Industry:-A-Proposed-Safety-Framework
Cannabinoids

Ensuring Safety in the Booming CBD Industry: A Proposed Safety Framework

The rapid growth of the cannabis market has outpaced the establishment of comprehensive safety standards and regulations. To help create a pathway towards safe, secure, and reliably-regulated CBD products, Cristelle Santos, Consultant Toxicologist at Broughton, has proposed a safety framework.

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Whitepapers

Whitepaper:-The-Use-of-Risk-Assessments-to-Optimize-your-Extractables-and-Leachables-Strategy
Pharmaceutical

Whitepaper: The Use of Risk Assessments to Optimize your Extractables and Leachables Strategy

Extractables and leachables (E&L) risk assessments are valuable processes that can identify and highlight the risks of potential leachables from both the container closure system and the manufacturing processes. The risk assessments also include the level of risk that leachables might present to user safety and product quality. Download this Whitepaper to learn more.

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Whitepaper:-Nicotine-Pouches:-An-Extraordinary-Opportunity-to-support-Tobacco-Harm-Reduction
Nicotine

Whitepaper: Nicotine Pouches: An Extraordinary Opportunity to support Tobacco Harm Reduction

There is no doubt that the reduced-risk industry today is at an impasse, although there is now common acceptance that combustible cigarettes are the most hazardous form of nicotine delivery due to the accompanying harmful chemicals produced from tobacco combustion.

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Whitepaper:-Why-Cannabinoid-analytical-methodologies-are-the-foundations-of-building-a-mainstream-cannabis-industry
Cannabinoids

Whitepaper: Why Cannabinoid analytical methodologies are the foundations of building a mainstream cannabis industry

In this whitepaper, we discuss the range of validated analytical methods required to support the comprehensive characterization of various dosage forms of cannabinoid products. 

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Whitepaper:-Improving-the-Sustainability-of-Pressurised-Metered-Dose-Inhalers
Pharmaceutical

Whitepaper: Improving the Sustainability of Pressurised Metered Dose Inhalers

Since their introduction in 1956, pressurised metered dose inhalers (pMDIs) have become the dominant treatment choice for patients suffering from common respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD). However, unbeknown to most patients and many doctors, pMDIs account for 3.9% of NHS’s annual carbon emissions. 1Here we will discuss how formulation changes might be the answer to the pMDI-related sustainability problem.

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Whitepaper:-Does-CBD-Really-Harm-the-Liver?
Cannabinoids

Whitepaper: Does CBD Really Harm the Liver?

Both the FDA and EFSA have raised several concerns about CBD as supplements and as an ingredient in food and drinks, citing potential liver damage as a possible side effect. Is CBD really that toxic to the liver? To find out, toxicologist Cristelle Santos looks at the scientific evidence.

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Strategic-Insights-to-reignite-PMTA-confidence
Nicotine

Strategic Insights to reignite PMTA confidence

Dr. Nveed Chaudhary Chief Scientific and Regulatory Officer,  Paul Hardman Managing Consultant Chemistry and Manufacturing Controls, and, Libby Clarke Managing Consultant Toxicology share their thoughts on how to reduce costs and protect timelines while continuing to innovate.

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

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

Broughton summarises the regulatory pathways available for cannabinoid products in the UK market and the legal requirements for each potential market route. 

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Whitepaper:-The-importance-of-the-human-endocannabinoid-system-when-developing-therapeutic-cannabis-products
Cannabinoids

Whitepaper: The importance of the human endocannabinoid system when developing therapeutic cannabis products

To develop cannabis products that can both enhance the quality of life of cannabis users and comply with current and future regulations, we believe that fi rst we need to understand what cannabis is, how people use it, and how it affects the human body and mind. This white paper aims to provide essential but concise information about these areas, supported by scientific evidence.

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Whitepaper:-Review-of-the-degradation-pathways-of-cannabinoids,-the-potential-impact-on-medicinal-and-consumer-products,-and-discussion-of-mitigation-solutions-
Cannabinoids

Whitepaper: Review of the degradation pathways of cannabinoids, the potential impact on medicinal and consumer products, and discussion of mitigation solutions

In this whitepaper, Broughton discusses the susceptibility of cannabinoids to degrade and summarizes the main degradation pathways of the primary cannabinoid products on the market; tetrahydrocannabinol (THC) and Cannabidiol (CBD). 

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Poster:-E-Cigarette-Regulatory-Non-Compliance-in-the-UK-Marketplace
Nicotine

Poster: E-Cigarette Regulatory Non-Compliance in the UK Marketplace

Our Senior Consultant, Malcolm Saxton presented a poster at the 76th Tobacco Science Research Conference in Norfolk, Virginia USA about ‘E-Cigarette Regulatory Non-Compliance in the UK Marketplace’.

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