We love to help build things—the more complex, the better. Our full-time professional staff helps biopharmaceutical and medical device companies build new plants, expand or re-purpose existing facilities, commission or decommission equipment. Some clients ask us to plan, orchestrate and manage the entire project—equipment, facilities and utilities. Others need our help on just a single element of their project. We have the expertise and the ability to scale to meet any of your requirements.
From planning through documentation, testing and start-up, ICQ will help keep your capital project on schedule, on budget—and in compliance—while making sure the facility is up and running as quickly and efficiently as possible.
We help companies with all facets of validation, setting high standards and looking for 100% right-first-time performance. Whether it’s a targeted review of protocols and documentation, or full-scale validation program development from planning through execution and, ultimately, regulatory approval, ICQ experts will help you get the job done.
At manufacturing facilities, both large and small, we have been directly responsible for ensuring that appropriate standards were established and adhered to for all validation activities. We can also help you update current CQ&V strategies to meet changing regulatory guidelines, or to bring your program into alignment with current industry practices.
Quality teams are simultaneously essential and constrained. Nothing ships without quality assurance, yet quality teams can be overburdened with audits, responding to regulatory actions, or implementing new programs. This is where ICQ can help.
We work closely with quality leaders and staff to evaluate qualityprocedures, develop and execute mitigation plans, create documentation and reporting systems that are efficient, reliable and consistently reproducible.
Staying ahead on quality is always the best strategy, so we help quality teams develop and/or implement a scientific quality risk management (QRM) approach at every stage—from design of unit operations, to identifying critical inspection and testing points, to developing SOPs, training and documentation.