We prioritize adherence to stringent compliance and regulatory standards to ensure the highest quality and safety of our products. Our manufacturing practices strictly conform to Medical Device Standards and International Regulations, such as the Medical Device Regulation (MDR). Regardless of whether it involves contract development or life-cycle manufacturing, we maintain Good Manufacturing Practices (GMP) certification. GMP sets the minimum standards for drug delivery solutions and combination product manufacturers, helping us meet regulatory expectations and harmonize operations.

Our commitment to GMP encompasses control, quality, safety, and effectiveness. By following these standards, we safeguard patient safety and satisfaction. To stay at the forefront of a rapidly changing world, we embrace a Lean approach and employ process simplification methodologies.

In addition to GMP conformity, we also align with the guidelines provided by International Standardization Organizations, such as ISO. As a drug delivery device solution manufacturer, ADDIS adheres to ISO standards (ISO 13485) in our Quality Management System (QMS) for medical devices. By leveraging our expertise in GMP and ISO guidelines, we confidently deliver innovative solutions that meet the evolving needs of our customers and contribute to the advancement of healthcare.