GMP & Preclinical Production
We are able to work with clients on the development of procedures and controls, manufacturing processes and can assist with required testing for Phase I and II biologics. Under ISO 13485 and GMP guidelines, pre-clinical batches are manufactured to the highest standards in dedicated ISO-7, Class 10,000 clean rooms with processes and documentation customized to satisfy your specific requirements. We understand the level of manufacturing traceability that is required for pre-clinical phases of study. Our clients are assigned an experienced project manager who coordinates the entire process and works as a primary point of communication. Our team of experts can provide a detailed quotation for small pilot samples to commercialization of your product.
Call us today so we can send a non-disclosure agreement and start your project right away.