Quality, Certifications & Regulatory Compliance
At Prelia Biotech Group, quality is the foundation of everything we do. Our commitment to excellence is demonstrated through our comprehensive certifications, rigorous quality control processes, and dedicated regulatory support services.
Our Quality Policy
Prelia Biotech Group is committed to manufacturing diagnostic tests and dietary supplements that consistently meet or exceed customer expectations and regulatory requirements. We achieve this through continuous improvement of our quality management systems, investment in advanced technology, and ongoing training of our skilled workforce.
Our quality policy extends beyond compliance. We believe that quality is a competitive advantage that enables our B2B partners to build trust with their customers. Every product that leaves our facility carries our reputation—and we take that responsibility seriously.
Our Certifications
ISO 13485
Applies to: Golden Time (IVD)International standard for medical device quality management systems. Our IVD manufacturing facility maintains full ISO 13485 certification, ensuring consistent design, development, production, and delivery of medical devices that meet both customer and regulatory requirements.
GMP
Applies to: Both BrandsGood Manufacturing Practice certification ensures our production processes meet the highest quality standards. Both our diagnostic test and dietary supplement facilities operate under strict GMP protocols for cleanliness, equipment validation, personnel training, and documentation.
Halal Certification
Applies to: Golden DailyCritical for Middle East and Southeast Asia markets. Our supplement manufacturing facility holds Halal certification, ensuring all ingredients, processes, and packaging comply with Islamic dietary laws. This opens access to 1.8 billion Muslim consumers worldwide.
HACCP
Applies to: Golden DailyHazard Analysis Critical Control Point certification for our supplement facility. HACCP identifies potential food safety hazards and implements preventive controls throughout the production process, from raw material receipt to finished product dispatch.
ISO 22000
Applies to: Golden DailyInternational food safety management system standard. Our supplement manufacturing integrates ISO 22000 requirements with HACCP principles, providing a comprehensive framework for controlling food safety hazards across the entire supply chain.
CE Marking
Applies to: Golden Time (IVD)European conformity marking for medical devices. Our IVD products bear the CE mark, indicating compliance with EU In Vitro Diagnostic Regulation (IVDR) requirements and enabling legal sale across all European Economic Area markets.
Quality Control Process
Raw Material Testing
Every incoming material undergoes identity testing, purity analysis, and microbiological screening before acceptance into inventory.
In-Process Control
Critical process parameters are monitored continuously. In-process samples are tested at defined intervals to ensure batch consistency.
Finished Product Testing
Complete testing of every batch including potency, dissolution, disintegration, content uniformity, and microbiological limits.
Stability Testing
Accelerated and real-time stability studies ensure product quality throughout shelf life under various storage conditions.
Regulatory Support Services
We understand that navigating regulatory requirements can be challenging. That's why we offer comprehensive registration support to help our B2B partners bring products to market faster. Our regulatory affairs team has experience with authorities across multiple regions.
From initial documentation preparation to submission follow-up, we guide you through the entire registration process in your target markets.
Registration Support Regions
- European Union
CE Marking, Notified Body assessment
- Middle East
SFDA (Saudi), ESMA (UAE), GCC mutual recognition
- Southeast Asia
NMRA (Sri Lanka), BPOM (Indonesia), FDA Philippines, HSA (Singapore)
- Africa
National registration authorities, WHO prequalification support
- Latin America
ANVISA (Brazil), Cofepris (Mexico), INVIMA (Colombia)
Manufacturing Facility
Our state-of-the-art manufacturing facility features dedicated production lines for IVD diagnostics and dietary supplements. The facility includes ISO Class 7 and Class 8 cleanrooms for sensitive medical device assembly, climate-controlled storage for raw materials and finished products, and advanced analytical laboratories for comprehensive quality testing. Our production capacity supports high-volume OEM orders while maintaining the flexibility for custom small-batch runs.
Need Product Registration Support?
Our regulatory affairs team can help you navigate registration requirements in your target markets. Contact us to discuss your specific needs.