Comprehensive drug product and drug substance chemistry, manufacturing and controls (CMC) analytical support services for the biopharmaceutical industry.
Accessing markets for complex biopharmaceutical products can be difficult and time-consuming. Analytical CMC testing helps identify, assess and demonstrate the safety, effectiveness and consistency of complex biopharmaceutical products, thereby accelerating the journey to approval.
We offer a full range of CMC analytical testing solutions for biologic product development, supporting novel therapeutics and vaccines. Through a global network of state-of-the-art testing facilities, our internationally recognized experts provide support at every step along the product development lifecycle, so you can confidently verify the safety, effectiveness and consistency of every dose of your biopharmaceutical product.
Our scientists will verify the safety of your biologics, performing identity, purity, potency and functional testing to support and demonstrate the stability of your product throughout its shelf life. We cover all stages – from analytical development and validation to container closure systems, physical and physicochemical properties. Our microbiologists verify the microbial safety of your materials throughout their shelf life.
Operating within globally recognized quality standards, we deliver accurate, high-quality data that supports your CMC journey. Wherever you operate in the world, our experts help you ensure the ongoing quality and compliance of your biopharmaceutical products.
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Av. De las Américas, Centro de Convenciones, empresarial 2 oficina 6,
090505,
Guayaquil, Ecuador