We had the pleasure of being able to attend Extractables & Leachables (E&L) Europe in Amsterdam this month which provided a deep dive into ....

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?
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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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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.
Click to downloadWith 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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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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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.
Click to downloadLooking 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.
Click to downloadWe help companies of all sizes through the product lifecycle stages, from concept innovation, product realization, and regulatory submission to post marketing surveillance.
Click to downloadThe MHRA is now a stand-alone body issuing national authorizations only. This infographic outlines the routes to a Pharmaceutical Marketing Authorization in the UK.
Click to downloadThe evaluation of extractables and leachables (E&L) is an essential component of the pharmaceutical development process.
Click to downloadOur 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.
Click to downloadDeveloping 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.
Click to downloadLearn more about our UK and EU Novel Food Application scientific consultancy and analytical testing support.
Click to downloadOur 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.
Click to downloadWe believe that the sectors we work within expect a continually improving service where we constantly strive to improve processes and Quality.
Click to downloadLearn 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.
Click to downloadThe 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.
Click to downloadExtractables 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.
Click to downloadThere 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.
Click to downloadIn this whitepaper, we discuss the range of validated analytical methods required to support the comprehensive characterization of various dosage forms of cannabinoid products.
Click to downloadSince 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.
Click to downloadBoth 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.
Click to downloadDr. 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.
Click to downloadBroughton summarises the regulatory pathways available for cannabinoid products in the UK market and the legal requirements for each potential market route.
Click to downloadTo 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.
Click to downloadBroughton summarises the ‘historical’ development plan for pharmaceuticals, the changes that have occurred with regards to differential development including the requirements for biologicals, the typical challenges the industry faces now and, in the future, the opportunities this brings. This white paper forms a simplified reference point for developing pharmaceuticals both now and in the future, and some of the choices/challenges companies have
Click to downloadIn 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).
Click to downloadOur 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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We had the pleasure of being able to attend Extractables & Leachables (E&L) Europe in Amsterdam this month which provided a deep dive into ....
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Broughton releases infographic to help establish comprehensive safety standards for CBD ~.
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Broughton CEO, Chris Allen, has written a letter to the Editor of The Grocer in response to a recent article they published about underage vaping.
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