- Improving productivity to gain innovation
- The squeeze on capital budgets, with the associated depreciation
- Evolving regulatory requirements
Please contact us and we can discuss the right solution for your business.
The US Food and Drug Administration (FDA) has been exercising enforcement discretion for laboratory developed tests (LDTs) and is now proposing to regulate these products. Manufacturing under cGMP regulations can be a confusing, costly, and time consuming process. By choosing Argonaut you can be assured that your products will meet all compliance requirements. We provide quality oversight in all processes from receipt to release. We take each client’s needs into account and work closely with you to customize a quality plan that works for you, regardless of size or complexity of project.
Argonaut is a reliable, trustworthy CMO with over 100 years of combined experience in the industry. We act as a highly qualified, transparent partner with state-of-the art quality and regulatory systems and are always available for client and US regulatory audits and inspections.
This is a big question and we refer you to our white paper written by our CEO, Wayne Woodard.
With years of international experience, our team understands the world is a smaller and smaller place every day. Advancements in technology enable us to work with a client virtually anywhere. We have chosen Carlsbad, California to be located near one of the leading centers of innovation excellence and talented workforce.
There are a number of differences but the most fundamental is a 100% dedication to the life science consumables markets. We are built from the bottom up to be a cGMP manufacturing site, with regulated market requirements in mind from the beginning. With over 100 years of operational experience in the leadership team alone, there is rarely a supply chain challenge that we haven’t faced. Our quality system is established as a state-of-the-art electronic system, rather than an inherited paper based system.
Very secure. Utilizing some of the best cloud based tools available today we “vault” client’s protocols and methods in our e-Quality management system. Access to this process documentation is strictly controlled to those qualified and trained on the SOP’s and QC requirements.
No, Argonaut is a services company. We will never sell products or compete with product innovators. Our client’s intellectual property is of the highest priority to us and we safeguard this with state of the art information technology and strictly controlled access.
Argonaut is dedicated to providing reagent and consumable contract manufacturing services for Molecular Diagnostic and Life Science companies. Our services span all aspects of the modern supply chain from new product introductions (NPI) and project planning to supplier management, manufacturing and global logistics requirements.