Risk Assessments
We help you to document your E&L risks based on probability and severity, and provide solution focused recommendations to meet regulatory standards.
Extractables
We perform high quality extraction studies to assess the risk of harmful compounds migrating into your products.
Leachables
We conduct ICH compliant leachable studies on your behalf, providing expert advice and method development / validation to support you through the regulatory process.
About Us
Operating from a state-of-the-art laboratory in Oxfordshire, we are dedicated to delivering high quality, comprehensive extractables and leachables risk assessments, testing and recommendations.
As seasoned experts in the pharmaceutical, consumer health, and medical device industries, we specialise in handling a diverse range of products including OINDP (orally inhaled and nasal drug products), parenterals, ophthalmic drug products, and medical devices. We also have a wealth of experience in consumer health products such as topical and oral liquid formulations.
We operate under the ISO 17025 standard, developing and validating methods according to ICH Q2(R2) to ensure that any data generated can be used for regulatory submissions.