- Pharmaceutical and Biologics Company (Multi-product) – Set up SOP system for use in virtual company. Established quality agreement with major European pharma supplier. Assisted in set up of world-wide clinical product distribution system and provided QA support. On a second project, worked with Asian manufacturer on PAI preparations. (4 years)-Biologics (Monoclonal antibody) – Managed QA activities for an Asian company operating in the US. Provided QA management for ongoing clinical studies from setting up a Quality Agreement with two major pharma operations in the US, to product batch release and oversight of clinical shipping operations. (2 years)- Biologics (Monoclonal antibody) – Provided QA support for set up of a virtual biologics company to include quality management for CMO development and production of bulk drug substance. Also set up a QC laboratory to include QA procedures, an equipment qualification system, and personnel training (1 year). - Pharmaceutical (Transdermal Product) – Provided GMP training and Pre-Approval inspection training for an international pharmaceutical company. Evaluated parent firm and CMO operations for compliance and readiness for FDA inspection (6 months). - Biologics (Multi-product) – Reviewed responses to European and US regulatory authorities relative to Warning Letters following inspections and US Consent Decree (6 months). - Multiproduct, Over-the-Counter Manufacturer – Worked on remediation plan and work plan following a US Consent Decree (3 months).

Assisting with Preapproval Inspection preparations at Japanese contractor manufacturer.

Helped to set up GMP QC lab operations.