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Our in-house expertise and flexible manufacturing lines provide excellent, rapid solutions for your combination product.
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Unlike others, Argonaut has a background in both devices and pharmaceutical fill finish. It is this fusion of foundational knowledge and regulatory systems that is key to combination product manufacturing.
Our in-house expertise and flexible manufacturing lines provide excellent, rapid solutions for your combination product.
Argonaut helps simplify your supply chain by consolidating steps in-house. Our purchasing controls are QSR compliant.
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 including Part 4 update, 21 CFR 210, 21 CFR 211, and Argonaut is FDA registered and CA FDB inspected (link to certificates).
– Vice President Of Clinical Development Operations Boston-based Biotech Company
We align your target goals with combination product 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.
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.
CDMOs play a crucial role in ensuring the quality of the products they manufacture and maintaining compliance with applicable regulations.
To achieve this, reputable CDMOs like Argonaut implement a comprehensive approach that includes the following elements:
Quality Management System (QMS): A robust QMS is the backbone of a CDMO’s quality and compliance efforts. The QMS includes policies, procedures, and guidelines that govern every aspect of the life science and IVD manufacturing process, from raw materials sourcing to finished product release.
Compliance with Good Manufacturing Practices (GMP): CDMOs adhere to GMP guidelines and other relevant industry standards to ensure that products are consistently manufactured according to quality requirements. GMP guidelines cover various aspects of the production process, including personnel qualifications, equipment maintenance, and record-keeping.
Regulatory expertise: CDMOs employ experienced regulatory affairs professionals who are knowledgeable about local and international regulations, industry standards, and best practices. These professionals help ensure that the CDMO stays up-to-date with the latest regulatory changes and maintains compliance throughout the life science or IVD manufacturing process.
Regular audits and inspections: CDMOs undergo regular audits and inspections by both their clients and regulatory authorities to verify that they maintain compliance with applicable regulations and quality standards. These inspections help identify potential issues and ensure that corrective actions are taken promptly.
Employee training: CDMOs invest in continuous training and education for their employees to ensure that they have the necessary skills and knowledge to maintain quality and compliance. This includes training on relevant regulations, industry standards, and best practices.
Quality control and assurance: CDMOs implement rigorous quality control (QC) and quality assurance (QA) processes throughout the life science and IVD manufacturing process. QC involves testing and monitoring of raw materials, intermediate products, and finished products to ensure that they meet established specifications. QA focuses on the overall quality management system and helps identify and address potential issues before they impact product quality.
Documentation: CDMOs maintain thorough and accurate documentation of their life science and IVD manufacturing processes, quality control results, and compliance efforts. Proper documentation is essential for demonstrating compliance with regulations and facilitating audits and inspections.
Continuous improvement: CDMOs are committed to continuous improvement in their quality and compliance efforts. They regularly review their processes, systems, and performance to identify areas for improvement and implement necessary changes.
By implementing these measures, reputable CDMOs like Argonaut can ensure that they consistently deliver high-quality products while maintaining compliance with applicable regulations. Partnering with a CDMO that prioritizes quality and regulatory compliance can provide peace of mind and help minimize potential risks associated with life science or IVD manufacturing.
Get a turn-key manufacturing service that works for you.