CMC, Single Use Technology & Continuous Improvement Advising for Business Growth
Our Areas of Expertise
Single Use Technology
Tech Transfer & Commercialization
Quality & Continuous Improvement
Scale From Clinical To Commercial
We are more than staff augmentation. We are experienced individuals with years of R&D and Manufacturing experience to help your operations scale, reduce costs, improve quality and gain efficiencies in manufacturing. We thrive on solving difficult and critical problems.
Case Study
Our client was performing an increasing volume of raw material testing for a major supplier and was given a questionnaire. We worked with the client to build enhancements into their quality system to better align with relevant aspects of ISO 13485, ICH guidance and GMP and GLP best practices. We put special emphasis on document and data management and aspects of CAPA. The questionnaire was returned to the supplier and the client successfully passed assessment and remains in good standing