At ACTO^® Pharma, our commitment to safety, reliability, and superior quality is anchored by a robust framework of international certifications. These credentials serve as a global validation of our internal processes, manufacturing integrity, and the high-performance standards of our final products.

International Management System Certifications

We adhere to the following internationally recognized management standards to ensure operational excellence and continuous improvement across all organizational levels:

• ISO 9001: Quality Management System – Ensuring consistent quality and operational efficiency.

• ISO 13485: Medical Devices — Quality Management Systems – Demonstrating our specialized competence in the medical device industry.

• ISO 45001: Occupational Health and Safety Management System – Prioritizing a safe and healthy environment for our workforce.

• ISO 10002: Customer Satisfaction Management System – Highlighting our dedication to customer-centricity and effective feedback management.

• HACCP: Hazard Analysis and Critical Control Points – Certified by the Ministry of Agriculture, ensuring biological, chemical, and physical safety in our relevant production lines.

Regulatory & Manufacturing Compliance

We operate in strict alignment with national and international health authorities to provide products that are both safe and effective:

• Good Manufacturing Practices (GMP): Our facility proudly holds the GMP certificate issued by the Ministry of Health. This certification is a definitive proof of our adherence to the highest manufacturing hygiene, safety, and traceability standards.

• CE Certification (93/42/EEC MDD): Our medical device disinfectants, wound care solutions, and other medical supplies are CE-certified in accordance with the Medical Devices Directive. We proactively monitor and adapt to evolving regulations, such as the Medical Device Regulation (MDR), to ensure uninterrupted compliance and safety.

• Biocidal Product Licensing: Every product within our biocidal range is manufactured and licensed under the strict framework of Biocidal Product Regulations, ensuring legal and safe market placement.

By integrating these world-class standards into our daily operations, ACTO^® provides its global partners and end-users with the highest level of trust and quality assurance.