Understanding the chemistry of your products
Broughton is a Contract Research Organisation ( CRO ) equipped to offer full analytical services to evaluate the chemistry of nicotine pouches, e-liquids, captured aerosol, devices and all forms of packaging container systems for the NGP industry.
By partnering with us, you will have access to some of the most experienced scientific consultants and chemists who are committed to developing safer nicotine products.
Our team understand the regulatory challenges and unique opportunities within the NGP industry. We will work with you to ensure your current and future products are safe, compliant, and commercially successful. We appreciate that your requirements are not generic, so neither is our approach.
Maintaining regulatory compliance is a key factor in keeping your Electronic Nicotine Delivery Systems (ENDS) products on the market. Although ENDS are shown to have less adverse effect on human health than traditional combustible tobacco products, harmful and potentially harmful constituents (HPHC’s) may still be produced using these products.
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Stability storage is provided in purpose built walk-in climatic chambers located in a controlled area. The chambers are controlled via a fully validated data management system in accordance with FDA requirements and ICH harmonized guidelines for stability testing of new drug products and substances. Each chamber is temperature and humidity controlled to +/-2°C and +/-5%RH of its target conditions, with 24hr monitoring of chamber conditions.
Broughton has extensive experience of designing ENDS stability studies in support of regulatory applications. Stability studies can be conducted at a number of different temperature and humidity conditions, including real-time, in-use and accelerated conditions in-accordance with ICH Q1A(R2).
Our dedicated team will help you manage the quality and safety of your products throughout their lifecycle providing reassurance and support. Batch testing and investigatory analysis guarantees product quality ensuring the protection of public health.
Using a wide range of analytical techniques, we provide QC testing of raw materials and finished products. Our laboratory is equipped with an extensive suite of high-end analytical instruments and aerosol collection rigs.
Our team of scientific and regulatory experts, backed by an in-house custom-built CRO facility, understand your specific challenges and opportunities and are committed to working with you to increase the value of your business and create a smoke free-future.
From basic questions to complex compliance inquiries, we're here to help! Contact us today.
Broughton is committed to helping our clients deliver life-enhancing products to market, by providing the most trusted integrated services in the world.
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