I am an Analytical Chemist by training, for over 20 years I have directed scientific study and created  regulatory documentation to meet the ongoing regulatory requirements in extractables and leachables (E&L).

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I have written or overseen 20+ regulatory submissions sections in the topic area of E&L. These include a wide variety of different dose forms and regulators.

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These submissions contributed to the 1st time approval of many products including MDIs, DPIs, ANS, Topicals, Biopharmaceutical and Small molecule Parenterals, plus the 1st approved Gene Therapy product for ADA-SCID - Strimvelis.

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I established a single internal systematic approach to extractable and leachable testing for a multi-national pharmaceutical company, introducing a technical risk assessment process and template, using a bespoke Failure Mode Effects Analysis (FMEA) process.

 

This approach, which is closely aligned to ICH Q9 (Quality risk management) provides documented justification for testing then undertaking (extractable tests or leachable ) saving time and money by focusing only on activity which is scientifically justified. This approach formed the basis of the company's international policy document.

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I have developed and delivered training seminar on science led risk based approaches to E&L

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I regularly present and chair sessions at international conferences on the topic of E&L

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Let my experience bring Expert Consultancy to your next project

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