Our story is one of partnership and innovation. Using your CE Mark or other framework as a baseline, we can help guide you through U.S. regulatory requirements. We only perform manufacturing services, so we will never compete against your products – and we are experts in biotech manufacturing in the United States.
Our team has extensive experience in technology and product transfer, from simple to complex projects. Working with your BOM we source either identical or comparable parts and engage our Ecosystem Partners to get the best solution. You are also assigned a dedicated project manager, so communications are seamless.
Prioritizing quality from day one, the Argonaut Quality Management System is the overarching structure that houses all other systems, including ERP. Argonaut’s Quality Management System is compliant to ISO 13485:2016, cGMP, and quality system regulations 21 CFR 820, 21 CFR 210, 21 CFR 211, and Argonaut is FDA registered and CA FDB audited.
Armed with advanced automated aseptic fill finish manufacturing equipment, Argonaut can reduce contamination risk, helping ensure the safety and quality of your products at every stage of the manufacturing process.
Most CDMO’s will say they have state-of-the-art facilities, but few continue to invest in the future of biotech manufacturing in the United States like Argonaut. Our investment in equipment and technology means you don’t have to invest – we did it for you.
Get manufacturing that is customized to your needs. Argonaut provides a broad range of operational solutions including:
– Vice President Of Clinical Development Operations Boston-based Biotech Company
Every journey to contract manufacturing is unique. Some biotech companies know, at the start, they want to work with a contract manufacturing organization (CDMO), while others choose to engage a CMO later in the product design process or even after production has started.
These FAQ’s will help you better understand what you need to be considering no matter what stage you are in of early, late, and post-production engagement.
Get a turn-key manufacturing service that works for you.