In the pharmaceutical industry, regulatory compliance is the line between success and setbacks—and Lyomac has built its legacy on mastering this critical requirement. Since 2009, we have delivered over 200 freeze drying systems to more than 15 countries, each fully compliant with cGMP, GAMP5, and FDA standards. What makes our approach stand out is that compliance isn’t an afterthought—it’s woven into every stage of our process, from initial design to final validation. Our product range, spanning laboratory (up to 12L), pilot (up to 150L), and industrial (up to 1000L) freeze dryers, ensures that whether you’re a biotech startup in R&D or a multinational scaling commercial production, you never compromise on regulatory alignment.
Take our industrial freeze dryers, for example: with shelf flatness ≤1mm and temperature uniformity ≤1°C, they guarantee consistent product quality batch after batch—essential for passing strict audits. We also provide comprehensive documentation packages, including IQ/OQ/PQ protocols, to streamline your regulatory submissions. Backed by certifications like UL, CE, ASME, and CSA, our equipment meets global standards, opening doors to international markets. Our team of regulatory experts stays updated on evolving requirements, ensuring your systems remain compliant for years. For pharmaceutical companies navigating the complex regulatory landscape, Lyomac isn’t just a supplier—we’re a trusted partner that turns compliance into a competitive advantage, reducing risks and accelerating time-to-market with confidence.
