
Broughton
Analytical testing and regulatory consultancy for pharmaceutical and specialty products.
Listed on cro.directory
Global CRO specializing in analytical testing, regulatory consultancy, and compliance support for pharmaceutical, tobacco, and cannabinoid products across FDA, EMA, and other regulatory pathways.
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About this organization
Broughton is a contract research organization with over 15 years of experience in analytical testing integrated with scientific consultancy and regulatory compliance. The organization provides regulatory advice at every stage of project development, from study design and data interpretation through regulatory dossier construction and agency submission support. Their expertise spans analytical method development and validation, stability studies, extractables and leachables testing, and toxicological assessment.
The firm maintains a commitment to quality through risk-based decision-making, continuous improvement, and internal compliance monitoring. Broughton offers comprehensive services to support manufacturers navigating global regulatory frameworks, including preparation for regulatory inspections and meetings. The organization has established specialized capabilities in heated tobacco product (HTP) testing, cannabinoid and nicotine analogue research, and compliance guidance across multiple jurisdictions including the US (FDA/PMTA), European Union (TPD/TRPR), and UK regulatory systems.
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