Quality Management

Quality Management
At Bilim Pharmaceuticals, our corporate Quality Assurance (QA) system is engineered to foster synergies and cultivate best practices across the organization. This robust framework is supported by a dual contribution structure from both our headquarters and individual Quality Unit Teams at our manufacturing sites. Operationally, we ensure alignment and seamless information sharing through daily cross-functional collaboration among various experts and teams.

We undergo regular inspections by regulatory bodies in all markets where our products are distributed. Our facilities are routinely reviewed by local and international regulatory agencies, ensuring our operations meet global standards. Since the activation of the EU-FDA Mutual Recognition Agreement (MRA) on GMP inspections in November 2017, our compliance with these stringent requirements has been recognized, reducing the frequency of routine surveillance inspections by the FDA in countries with robust inspection capabilities, such as Italy.

Regulatory Inspections
Bilim Pharmaceuticals’ production facilities adhere to the highest international standards and are subject to frequent inspections by prominent national and international medicinal regulatory authorities. These include the FDA (USA), AIFA (Italy), AEMPS (Spain), the Russian Health Authority, PEBC (Canada), COFEPRIS (Mexico), TGA (Australia), PMDA (Japan), KFDA (Korea), ANVISA (Brazil), and the WHO. Such rigorous oversight ensures that our practices meet the stringent quality and safety standards required in our diverse global markets.

Through continuous improvement and adherence to international compliance, Bilim Pharmaceuticals remains at the forefront of pharmaceutical innovation and quality, contributing to better health outcomes worldwide.