The ACI’s Regulatory and Compliance Unit, forms our Regulatory Consultancy Team, they ensure our members are fully compliant in all regulatory aspects concerning CBD and other legal cannabinoids.
The Regulatory and Compliance Unit provides a critical bridge between our members and the key regulatory bodies in the UK and Europe, whom we are in close and constant contact with.
With over 100 years of combined experience in the regulatory environment The ACI’s Regulatory and Compliance Team are ideally positioned to provide our members with the expertise, practical help and support they need to meet new and emerging regulatory compliance.
We provide a thorough gap analysis of your situation giving you a detailed checklist of any area where your business can be improved. With this information you maximise your chances of gaining the full legal compliance you require to enable you to keep your products on the market.
The ACI’s Regulatory and Compliance Unit can offer assistance in preparing, the now obligatory, novel foods scientific dossiers for each of your products. This way you can be confident that your novel foods applications cover everything required to gain the status of “novel foods validation” before the FSA’s 31st March 2021 deadline.
Dr Parveen Bhatarah, Regulatory and Compliance Unit Lead
Parveen has over 20 years experience in Pharmaceutical Innovation and international pharmaceutical regulatory experience (MHRA, TGA, ANVISA, EMA, Asia, and Chinese Health authorities). Moreover, Parveen has 12 years experience in the Medicinal Cannabis industry, covering everything from medicinal cultivation to FDA approval of finished products.
Dr Paul Duffy, Toxicologist
Over 30 years toxicology/safety evaluation experience in the pharmaceutical industry (ICI, Zeneca, AstraZeneca) over a wide range of therapeutic areas including cancer, inflammation, pain, infection, neuropsychopharmacological therapies. Responsible for the non-clinical safety programmes of potential new therapeutic agent development from discovery to drug registration across global territories including US/Canada, Europe, Japan and China.
A European Registered Toxicologist (ERT), a founding member of the In Vitro Toxicology Society and has served on committees of US Society of Toxicology and British Toxicology Society and is a Fellow of the BTS and a Fellow of the Royal Society of Biology. In 2015 Paul became an independent consultant and Associate of ApconiX Ltd with whom he is senior project toxicologist with particular experience in neuropsychopharmacology related therapeutics.
Penny Schenkel, Senior Regulatory and Compliance Assistant
Penny ran her own regulatory consultancy before joining the Resolution Chemicals team in 2017. Penny has held various regulatory roles in the generic and branded pharmaceutical industry and has accrued over 20 years of experience in pharmaceutical development, technology transfer and manufacture for European MAA applications. She has worked efficiently with multiple regulatory agencies across Europe and most recently focussing on the UK market.
Isabel Alber, Regulatory and Compliance Consultant
Isabel is a Food Scientist with 25 years experience in the Food Industry in all sectors and continents. She specialises in Food Safety and Quality Management Systems [ISO 9001, FSSC 22000, BRC, IFS], both in certification as an international third party auditor and as a Consultant in the UK and Europe, helping companies implement international standards and retailer’s codes of practice.
She has broad experience delivering training courses for both Third Party lead auditors and the implementation of Food Safety and Quality Systems.
Laura Eder, Regulatory and Compliance Consultant
Laura Eder has 17 years of experience in the life-cycle management of pharmaceuticals and medical devices and has had a Regulatory Affairs Certificate (RAC) since 2012. Based in Colorado, Laura held the position of Regulatory Manager at Mile High Labs (MHL). MHL were the first ACI members to submit their CBD novel foods dossier giving Laura first hand experience of this process. Laura also helped guide MHL through several significant regulatory milestones, including ISO 9001:2015, GMP 111 (dietary supplements) and GMP 117 (food) certifications. She has over 15 years experience in working with the FDA and brings a wealth of experience in all regulatory aspects relating to cannabinoids.
Nicole Stone, Regulatory Data Assistant
Currently in her final year of doctorate study, Nicole has a range of experience including phytocannabinoid pharmacology, blood-brain barrier physiology and neurodegeneration. Nicole has worked on various projects in the field of cannabis research and was the 2019 winner of the pre-Doctoral Presentation Award at the International Cannabinoid Research society (ICRS), where she has presented her pioneering research over the past 3 years. During the course of her PhD she has published two first author papers, and has a further two second author papers to her name pertaining to cannabinoid research. Furthermore, Nicole has significant experience in the pharmaceutical industry, particularly regarding ADME studies, DDIs and bioanalytical science.
See The ACI’s novel foods consultancy page for further information on our consultancy services.
For more information on how to leverage this essential resource please contact us.