We provide manufacturing solutions for diagnostics & life science applications across a variety of needs, from Research Use Only to turn-key regulated diagnostics. With cGMP, FDA registration, and ISO 13485:2016 certification, we build quality into each step, every time.
Manufacturing isn’t easy – especially in Diagnostics & Life Sciences. That’s why our expert team is here to focus on manufacturing your product. From New Product Introduction to Long Tail product portfolios nearing the end of their life cycle, our team has the expertise to efficiently manufacture the high quality products you require.
Argonaut offers a complete suite of services from supply chain management, technical transfer, engineering development and first article builds, to cGMP manufacturing, and quality and regulatory services. Argonaut is here to support your operations in new product introductions, scaleup, ongoing manufacturing or surge support.
We are the fastest growing cGMP manufacturer in the Diagnostics & Life Sciences manufacturing space. Our adaptability and flexibility, combined with the leadership and experience of our team in world class facilities, enable us to effectively meet your needs. The COVID Pandemic of 2020 clearly demonstrates both the urgency and the advantage of cGMP manufacturing that is scalable, resilient, and nimble.
We have decades of combined manufacturing experience from RUO to IVD cGMP products. Argonaut utilizes continuous improvement processes (CIP) to advance our manufacturing technologies, and the training of our team. Importantly, we partner with you to share our experiences and enable your success.
Prioritizing quality from day one, the Argonaut Quality Management System is the overarching structure that houses all other systems, including ERP. We continuously build the leading capabilities as your supply chain, manufacturing, regulatory, and third party logistics partner.
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. Government and regulatory agency projects we have hosted include FDA, Japanese PMDA, European QP, BARDA, Health & Human Services, and Project Warp Speed.
Based on your quality control specifications we can assess a number of factors including: identity, compendial methods, pH, osmolality, viscosity, conductivity, particulates, bioburden, endotoxin, and headspace.
Stability studies require a dedicated effort across long time periods, often tying up resources for years. Partnering with Argonaut gives you the expertise and capabilities you need, without the headaches of managing chambers, storage conditions, or testing; allowing you to focus on pursuing pre-IND submission, clinical trials, or commercialization.
Whether you’re a small innovative company or a Fortune 100 company, Argonaut works closely in strategic partnership with many of the most well known companies in the industry. We look forward to you joining these powerful partnerships.
The largest companies know what’s at stake when choosing the right contract manufacturer. Argonaut to outsource new product introductions, long tail/non-core product lines and entire portfolios.
We align your target goals with manufacturing requirements to provide a clear roadmap.
We will suggest alternative approaches and tap our ecosystem partners to provide you a range of choices.
Your product is shipped and delivered with finalized cGMP documentation.
Quality is the key to biotech manufacturing and Argonaut can assist your efforts, from preclinical through commercialization. Our dedicated team, equipment, and expertise supplements yours. (No hyperlink)
Preventing defects from entering your product build gives you confidence the standards you establish are being met. Argonaut can help qualify systems and suppliers, inspect reagents or materials, and train staff on risk mitigation.
