At KONEXIO BIOTECH, our compliance service focuses on the evaluation, development, and implementation of GxP quality systems, including GMP, GDP, GCP, and GLP, to ensure that all operations comply with the industry's most stringent regulations. We provide specialized support for sterile manufacturing, following the EU GMP Annex 1, and conduct internal, external, and supplier audits both nationally and internationally. Our comprehensive approach to managing the master validation plan and its execution ensures that each process is properly controlled and documented, ensuring the quality and safety of pharmaceutical and healthcare products.

Furthermore, we manage the design and validation plan for software for healthcare products, ensuring that all computer systems meet the necessary quality standards. Our quality risk management, based on the ICH Q9 guideline, allows us to identify, assess, and control potential risks at every stage of development and production. At KONEXIO BIOTECH, we also specialize in the opening of pharmaceutical and healthcare product plants, offering a complete service from initial planning to final implementation, ensuring that the facilities meet all international regulations and standards.