- Publicly traded Canadian LP (Licensed Producer) – Implementation of ICH GMP Systems, leading to International GMP Certification
- Canadian LP – Merger and acquisition due diligence including audit to EU GMP guidelines required prior to acquisition
- California Type 7 Manufacturer – Performed all pre-licensing activity through delivery of operational management template, standard operating procedures specific to hydrocarbon extraction through thin wiped film distillation. Represented client to City Planning Commission, City Council, and Mayor, resulting in successful
- Canadian LP – EU GMP implementation including gap audit, project management and EU GMP implementation of large-scale multi-facility company. Developed corporate GMP and Quality Management
- DEA Schedule 1 FDA cGMP Compliant Applicant – Performed GMP facility design, FDA GMP compliance strategy for pharmaceutical grade research materials, application content development for Drug Enforcement Agency and Food and Drug Administration.
- Pharmaceutical supply chain audit of 6 sites for pharmaceutical development firm. Audited to FDA and EU GMP for Contract Manufacturing, ISO 17025 testing laboratory, Good Laboratory Practices for non-clinical laboratory, and Good Clinical Practices for clinical Contract Research
- West Coast Fruit and Vegetable Producer – Successfully aided client in facility design and quality management system build out to adhere to USDA & FDA regulations in their addition of cannabis (THC-rich) and hemp (CBD-rich) production
