We have been awarded ISO 13485:2016 certification from SOCOTEC Certification International. This indicates that our quality management system maintains stringent international standards for medical devices, including in vitro diagnostic assays.
To be certified ISO 13485, our materials, processes, products and services underwent rigorous and independent testing for safety, product performance or reliability. Specifically, the scope of the certifications covers:
- Manufacturing and distribution of buffers and molecular diagnostic reagents for the use in in vitro diagnostic medical devices
- Provision of standard and customised services for:
- DNA Sanger Sequencing
- Fragment Analysis
- Next-Generation Sequencing and
- Other molecular biology services for in vitro diagnostic medical devices
We are bizSAFE Level 3 certified, demonstrating our commitment to Workplace Safety & Health (WSH) and effective risk management. This certification recognizes our efforts in identifying, assessing, and managing workplace hazards to ensure a safe and secure environment for our employees, partners, and customers. Achieving bizSAFE Level 3 reaffirms our dedication to maintaining high safety standards and compliance with Singapore’s WSH regulations.
We are a contract manufacturer operating in compliance with cGMP standards.
We adhere to Current Good Manufacturing Practice (cGMP) standards to ensure the highest quality and consistency in our contract manufacturing processes. By following cGMP guidelines, we maintain strict control over our production environment, materials, and procedures, ensuring compliance with industry best practices and regulatory expectations. Our commitment to these standards reflects our dedication to delivering reliable and high-quality products to our customers.