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.
Stability studies are essential in ensuring drug products remain safe, effective, and high-quality throughout their shelf life. While bundled services often include stability testing, hidden costs and limitations can create challenges.
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Broughton is a leading global contract research organisation specialising in tobacco harm reduction, medicinal cannabis, cannabinoids, and pharmaceuticals, we can help bring category innovators life-enhancing products to market.
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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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For category innovators thorough stability studies are vital for successful drug development and regulatory approval.
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The MHRA is now a stand-alone body issuing national authorisations only. This infographic outlines the routes to a Pharmaceutical Marketing Authorisation 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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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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ToxHQ by Broughton offers automated, data-driven risk assessments and delivers fast, high-quality toxicological evaluations, so you can launch safer products with confidence.
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In this whitepaper, we discuss the stability studies that may be performed during pharmaceutical development and in support of a regulatory dossier to support the licensing of a medicinal drug product.
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In this whitepaper, we discuss the stability studies that may be performed during pharmaceutical development and in support of a regulatory dossier to support the licensing of a medicinal drug product.
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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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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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The adaptation of e-cigarettes as drug delivery devices holds great potential for inhalation therapy. So, can we apply the advances made in nicotine delivery to other active substances?
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Navigating FDA and ICH Guidelines: Analytical Testing Validation for Tobacco Products.
Oral nicotine pouches have become a disruptive force in the reduced-risk nicotine product landscape.
Allergies concerns highlights need to meet stringent regulations ~.
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.
