Credence MedSystems, a developer of drug delivery technologies for pharmaceutical and biotechnology companies, has achieved ISO 13485:2016 certification for its Quality Management System, marking an important milestone in the company’s continued development as a commercial drug delivery partner. The certification, issued by BSI, recognizes that Credence has established a quality management system aligned with internationally recognized requirements applicable to the design and manufacture of medical-device-related products.

For pharmaceutical and biotechnology companies developing combination products, supplier quality systems are an important consideration as programs progress from development toward manufacturing and commercialization. Credence says the certification further strengthens its ability to support customers seeking drug delivery technologies backed by established quality and manufacturing infrastructure.

“ISO 13485 Certification is an important milestone in Credence’s evolution,” says Lisa Caparra, Director of Quality Assurance at Credence MedSystems. “We have built our business around solving difficult drug delivery challenges, but innovation alone is not enough. Pharmaceutical companies need delivery technologies supported by the quality systems, manufacturing processes and supply infrastructure necessary to move programs toward commercialization. This certification is an important demonstration of our evolution as a ready-to-supply partner for our pharma and biopharma collaborators.”

The ISO 13485 certification adds another component to Credence’s transition from a drug delivery technology developer toward a partner capable of supporting pharmaceutical and biotechnology programs through later stages of development and commercial preparation. For drug developers, evaluating a delivery technology involves considerations beyond device performance. Quality systems, design controls, manufacturing processes, supply infrastructure and the ability to support a program as it advances are all important elements of supplier qualification.

“Our customers are not simply looking for a device—they are looking for a solution to a drug delivery challenge, a lever for market differentiation, and a path to getting their therapy to the patients that need them,” says Sian Eden, Commercial Director at Credence MedSystems. “ISO 13485 certification strengthens Credence’s ability to support that journey. It is another important building block in our emergence as a partner that can bring innovative drug delivery solutions together with the quality and manufacturing readiness pharma expects.”

Credence’s approach is centered on its Innovation Without Change® philosophy: introducing new drug delivery capabilities while avoiding unnecessary complexity elsewhere in the product development and manufacturing process. The company develops platform technologies around established primary components and manufacturing processes. The goal is to give pharmaceutical partners greater flexibility to address specific drug delivery requirements while limiting implementation challenges and operational disruption.

Credence’s technology portfolio includes several platforms designed for different injectable drug delivery applications:

Companion® Platform: The Companion® Platform is a prefilled syringe system incorporating intuitive usability and passive integrated needle safety. The platform is available across industry-standard 1 mL, 2.25 mL, 3 mL and 5 mL syringe formats, with the expanded range intended to support the growing use of larger-volume injectable therapies while retaining the established Companion® architecture.

Dual Chamber Syringe Platform: Credence’s Dual Chamber Syringe Platform is designed to keep drug components separated until administration, enabling both reconstitution and sequential injection applications. The platform is intended for injectable therapies where formulation stability or other drug-product considerations can make conventional delivery formats challenging. Through specialized partners, Credence also supports associated dual-chamber requirements including filling, assembly, labeling and packaging.

Metered Dosing Platform: The Metered Dosing Platform provides controlled microliter dosing for single- and multi-dose applications, including ophthalmic and aesthetic therapies and other applications requiring precise delivery. The platform is designed to provide guided, controlled dosing while supporting the use of established prefilled syringe components and filling processes.

In addition to its platform technologies, Credence develops specialized solutions addressing specific drug delivery requirements, including technologies intended to mitigate needle clogging and support the delivery of high-viscosity formulations.

For more information, visit www.CredenceMed.com.