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Product & Partner Support

European GMP
Japan Foreign Manufacturer Accredited
ISO 13485 Certified for Medical Device
Registered FDA Device & Drug Establishment
We work with partners to provide high-quality, innovative product development and manufacturing solutions guided by our unwavering commitment to improving people’s lives. We’ve been achieving this goal and making progress possible since 1965.

QMS Compliance, Certifications, & Registrations

Supporting more than 25 commercial products, our multicompendial Quality Management System (QMS) includes:
Routine audits by international authorities have confirmed the robustness of our QMS, leading to an excellent inspection history over many years.


Following ICH Q8 guidelines, our QbD (Quality by Design) approach enables the development of a robust, efficient, and well-controlled manufacturing process.

Risk mitigation also includes contingency planning, such as the qualification of multiple vendors for difficult-to-obtain components.


Collaboration is led by a dedicated project manager with support from a cross-functional team.
Partners can expect leadership involvement and close relationships with experts across Lifecore. Many customers have partnered with us for more than 20 years.


YOU define the starting line with Lifecore. Partner organizations of different sizes and types select us to support their program’s unique scope of work at any phase.

Working with products across pre-clinical, clinical, and commercial has helped us develop flexibility within our
infrastructure and processes.