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.
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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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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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.
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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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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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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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The evaluation of extractables and leachables (E&L) is an essential component of the pharmaceutical development process.
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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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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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Learn more about our UK and EU Novel Food Application scientific consultancy and analytical testing support.
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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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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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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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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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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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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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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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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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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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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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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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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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Broughton 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
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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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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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We had the pleasure of being able to attend Extractables & Leachables (E&L) Europe in Amsterdam this month which provided a deep dive into ....
Broughton releases infographic to help establish comprehensive safety standards for CBD ~.
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.
Arrange a meeting with a scientific or regulatory expert to discuss your project and learn how we can help accelerate your product to market to maximize your success.
