Improving
Quality of Life
Helping you deliver life-enhancing products to market through analytical testing excellence integrated with best-in-class scientific consultancy and regulatory compliance.
Helping you deliver life-enhancing products to market through analytical testing excellence integrated with best-in-class scientific consultancy and regulatory compliance.
We are an independent life sciences contract research organization (CRO) serving a global roster of clients from Europe, the UK, North America, the Middle East, Asia, and Australia.
With over 15 years of analytical testing experience and a world-leading team of scientific and regulatory consultants, we help bring innovative products to market to improve societal health and well-being.
Our in-house laboratory testing facilities are GMP compliant and ISO/IEC 17025 accredited. We are regularly inspected by the Medicines and Healthcare products Regulatory Agency (MHRA), the US Food and Drug Administration (FDA), and the United Kingdom Accreditation Service (UKAS).
Our foundation is excellence in high-quality analytical testing integrated with the expertise in scientific strategy and the problem-solving necessary to navigate global regulatory pathways to maintain compliance. We believe science and innovation supported by appropriate regulatory frameworks contribute to a healthier world.
Whatever stage of your regulatory project, our scientific and regulatory consultants will bring years of industry experience and new insight. They are on hand to design and conduct studies, interpret data, construct your regulatory dossier, and submit it through the relevant agency-specific system. They will also help navigate your application through its entire process, including helping prepare for regulatory inspections or meetings.
Quality is one of the most important management principles for any organization, regardless of industry. We design quality into all our education and working methods, including our processes, risk-based decision-making, and change management. We rigorously monitor for internal compliance and continuous improvement to ensure the simplification of our systems. Everyone at Broughton is responsible for quality.
Helping accelerate next generation nicotine delivery products to market within their chosen regulatory framework to help make tobacco harm reduction a reality and contribute to a smoke free future.
Helping unlock the benefits of medicinal cannabis and CBD to address unmet clinical and therapeutic patient needs. Supporting a greater understanding of the science behind cannabinoids to ensure product quality, safety, and efficacy.
Supporting different stages of the device and product development lifecycle with a particular interest in novel inhalation and smart delivery systems. As experts in analytical testing and inhalation science, we believe device and formulation innovation can improve the efficacy and tolerability of drugs to improve patient care and deliver better health outcomes.
High-quality test data and additional scientific insight to fully understand results and troubleshoot problems.
Scientific strategy and consultancy to accelerate innovative products to market and ensure regulatory compliance.
Supporting better design decisions on device technology and drug/device combinations through independent advice, evaluation, and verification of new product technology or innovation.
Guide your product from material selection to market with in-depth insight through a safety assessment, active ingredient metabolism testing, and a full understanding of the toxicology of your excipients and impurities.
Reduce the cost and time of project implementation by meeting your U.S. Food and Drug Administration (FDA) compliance obligations. Improve your project’s planning and decision-making performance through the Environmental Assessment process ensuring potential adverse environmental effects are identified early.
Having gained extensive experience working within dynamic and rapidly evolving regulatory environments, we understand how new business opportunities are created and optimized in periods of uncertainty and change. We love working with partners who have an appetite for challenging the status quo and putting themselves at the forefront of medical or societal change.
Talk to us about your next project and learn how we can help you make it a success.
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