In the life sciences, "compliance" is a moving target. Whether you are preparing for an FDA inspection, transitioning to the latest Annex 1 requirements, or upgrading your cold chain infrastructure, Intruvu’s GxP consulting team provides the technical roadmap to ensure your operations are beyond reproach.
We bridge the gap between complex global regulations and your day-to-day operations, ensuring that your People, Processes, and Platforms are fully aligned with GxP standards.
Manufacturing
Distribution
Laboratory
Don't wait for a Form 483 or a Warning Letter. Intruvu performs comprehensive mock audits to evaluate your Quality Management System (QMS).
Don't wait for a Form 483 or a Warning Letter. Intruvu performs comprehensive mock audits to evaluate your Quality Management System (QMS).
In the digital age, data integrity is the top priority for regulators. We help you implement the ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, and Accurate).
InstruVU didn't just tell us what was wrong; they sat with us through the remediation process and the actual FDA inspection. Their expertise was the difference-maker.
GMP (Good Manufacturing Practice) focuses on the production phase, ensuring products are consistently produced and controlled. GDP (Good Distribution Practice) focuses on the supply chain, ensuring that the integrity of the product is maintained from the factory gate to the patient. Intruvu provides specialized consulting for both.
Depending on the size of your facility, a gap analysis typically takes 3 to 10 business days. This results in a comprehensive "Roadmap to Compliance" that prioritizes your most critical risks.
Call (888) 593-5069 or fill out the form and an expert will be in touch.
