- Improves operating costs
- Frees up valuable resources for new product launches or other priority initiatives
- Efficiently adapts to evolving regulatory requirements
Please contact us and we can discuss the right solution for your business.
Argonaut’s Quality Management System is compliant to ISO 13485:2016, cGMP, and quality system regulations (21 CFR 820).
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.
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 services company that is 100% dedicated to contract manufacturing. We will never be your competition so your intellectual property is safe. Argonaut has worked with companies of all sizes.
- Transforming fixed costs into variable costs
- Leveraging established supply chains
For more in-depth content here are our white papers.
Argonaut has successfully helped numerous clients based outside of California. Carlsbad may be our home, but our reach is global. We chose Carlsbad, California in order to be located near one of the leading centers of innovation excellence and talented workforce.
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. We utilize 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.
Lyophilization is currently available. Argonaut acquired LyoGen LLC in July 2018. With the acquisition of LyoGen, Argonaut expands its reagent lyophilization capabilities from process development through production scale deployment.
DPM will be available by Q2 of 2019. Argonaut’s DPM line will maximize product yield, reduce risk, and comply with all FDA and EU regulatory requirements.