We are now a cGMP certified contract manufacturer.
Our facilities have been assessed and certified by SOCOTEC Certification International as conforming to cGMP and customer requirements based on 21 CFR 820 for the manufacturing, kit assembly, and distribution of molecular biological reagents, buffers and culture media for the use in in-vitro diagnostic medical devices.
This certification assures proper design, monitoring, and control of our manufacturing processes and facilities.
We have been awarded ISO 13485:2016 and ISO 45001:2018 certifications from SOCOTEC Certification International. These certifications indicate that our quality management system maintains stringent international standards for medical devices, including in vitro diagnostic assays.
To be certified ISO 13485 and ISO 45001, 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
- Sales, distribution, machine commissioning/maintenance and manufacturing of 1st BASE's products including:
- DNA Sequencing Services
- Fragment Analysis Services
- Peptide Synthesis
- Antibody Production
- Protemics Services
- Biochemical and Ready to use Buffers and Molecular Biology Services
bizSAFE STAR is the highest level of accreditation in the bizSAFE journey, it signifies the organization's achievement of Workplace Safety & Health (WSH) Safety and Risk Management Excellence. This accreditation was granted in recognition of our efforts in managing health and safety hazards in and around our workplace, and is further testimony to our ability to meet international occupational health and safety standards.
To view our certifications, please download from below:
