Our Reference Standard Qualification services are designed to meet various regulatory requirements, including the 2-tier approach, and support your regulatory submissions and ongoing product quality control. Our Qualification Services Include:
- Qualification of Internal Reference Standard (IRS): Internal reference standards are essential for routine quality control. We help qualify these standards to ensure they are appropriate for use in analytical testing, providing reliable data to support batch release and stability testing.
- Qualification of Primary & Secondary Reference Standards (PRS/SRS): We assist in the qualification of Primary Reference Standards (PRS) and Secondary Reference Standards (SRS) to verify their identity, potency, and purity. These standards are critical for accurate and reproducible testing and for meeting regulatory requirements.
- Qualification for Biosimilars and Novel Products: For biologics, including biosimilars and novel products, we conduct detailed qualification to ensure that reference standards accurately reflect the product’s structure and function. Our services help demonstrate similarity, ensuring the quality of your biosimilar or novel biologic product.
- Qualification Per Regulatory Guidelines (ICH Q6B, ICH Q7): We ensure compliance with key regulatory guidelines, including ICH Q6B (for specifications and testing of biopharmaceuticals) and ICH Q7 (Good Manufacturing Practice for Active Pharmaceutical Ingredients). Our process ensures that your reference standards meet international regulatory expectations for quality, consistency, and stability.
By partnering with Aragen for Reference Standard Qualification, you can ensure that your biologic product meets the highest standards of quality and is fully compliant with regulatory requirements. Our rigorous testing processes provide confidence that your reference standards will support consistent and reliable testing, from development through to commercialization.