About

We are seasoned quality and validation management professionals specializing in implementing validation systems that meets FDA requirements and other regulatory compliance, following applicable standards and guidance documents such as USP, AAMI/ISO, ASTM, IEST and AATB.

We have over 20 years of combined experience between tissue bank and medical device industries, working in quality and validation-based roles.
Our focus also includes environmental monitoring, cleanroom qualifications, steam and gamma sterilization, project management, change control, root cause analysis, quality reviews, SOP development and staff training/development. We are very well versed in developing Master Validation Plans (MVP) and have a proven track record of performing validations for equipment, processes, packaging systems, transport container, and shelf-life.  We also perform quality/validation gap analysis to identify client needs and create action plans and manage complex projects, including regulatory compliance audits.