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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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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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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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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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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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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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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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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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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Contract research organization and scientific consultancy Broughton, appoints Dr Russ Svensen as director of consultancy services and a member of its ....
To celebrate National CBD Day in the U.
Broughton’s Chief Scientific and Regulatory Officer, Dr.
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.
