Regulated Testing
Achieve full regulatory compliance with our GMP-qualified QC testing for biologics and biosimilars, ISO 15189-accredited diagnostic services, and customized cell-based solutions.
Regulated Testing
Regulated Testing
Regulated testing is essential for demonstrating product consistency, safety, and efficacy under strict compliance standards. Our validated workflows help secure regulatory approval and maintain quality throughout manufacturing.
How we can help
Svar combines expertise in diagnostics, CRO services, and customizable products to deliver integrated solutions that meet the highest standards in regulated testing. By combining GMP and ISO 15189 standards with innovative technologies, we help you achieve regulatory compliance while optimizing efficiency and reliability.
From QC lot release and diagnostic services to tailored cell-based systems and WIESLAB® complement kits, our team works with you to ensure product integrity and accelerate development timelines.
Our solutions can assist in:
- Regulatory Compliance: Meets regulatory standards for QC lot release and stability testing.
- Quality Assurance: Ensures assay accuracy and reproducibility for critical decisions.
- Custom Solutions: Tailored assays for unique product requirements.
Our Regulated Testing Solutions
-
CELL-BASED BIOASSAYS
We establish potency methods that are representative of MoA and robust to manufacturing variation. Qualified assays are suitable for lot release, stability, and in‑process control with full documentation.
-
CELL-BASED BIOASSAYS
From feasibility through qualification or validation, we tailor assay design to product class and target biology. Technology transfer packages and SOPs enable smooth scale‑up and site implementation.
-
CRO & WIESLAB DIAGNOSTIC SERVICES
Our laboratories perform compliant testing under GMP and ISO 15189 standards, ensuring controlled environments, traceable reagents, and validated equipment. You receive audit‑ready data and reports aligned with regulatory expectations.
-
CRO SERVICES
End‑to‑end QC support covers method lifecycle, trending, and deviation management. Services integrate with your quality systems and supply chain timelines.
-
CELL-BASED SOLUTIONS
iLite® reporter cells and custom-designed cell systems provide consistent, sensitive readouts for functional release testing. Our assay‑ready formats reduce hands‑on time and variability in regulated environments.
-
COMPLEMENT ASSAYS
WIESLAB® complements regulated testing by providing pathway‑specific ELISAs for immune monitoring. Kits include controls and calibrators to maintain system suitability and data integrity.
Contact our team of experts
Write us a message and a product specialist will get in touch
