Kydea

About Kydea

Kydea operates at the intersection of GxP compliance, IT/OT engineering and digital innovation where pharmaceutical, biotech and medical device companies need a partner who understands both regulatory rigor and technology. For more than 20 years, our founding partners' pharmaceutical expertise has shaped how we work. Today Kydea is an ISO 9001:2015 and GMP-compliant company, helping manufacturers across the chemical, pharmaceutical, biotechnology, cosmetics and medical device industries meet FDA, EudraLex, PIC/S, ICH and AIFA requirements, without slowing down innovation. What we do IT/OT Compliance & Support: GxP systems SDLC, change & project management Computer System Validation & Qualification: CSV, IQ/OQ/PQ, equipment qualification Quality & Regulatory Consulting: compliance assessment, supplier audits, training Digital Solutions: data strategy, system integration and automation built for GxP environments Unlike pure compliance firms or generalist IT consultancies, we combine both: deep regulatory expertise and hands-on digital delivery helping life sciences companies make their processes more robust, efficient and governable over time, across the entire product quality life cycle. Headquartered in Latina, Italy, working with clients worldwide.