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Product & Partner Support

European GMP
Certified
Japan Foreign Manufacturer Accredited
ISO 13485 Certified for Medical Device
Registered FDA Device & Drug Establishment

Our Commercial Consultants

Jessica Miller

“I believe the success of our clients is the success of Lifecore, and that is how I foster true partnerships. Creating a trusting relationship is the first step toward accomplishing our common goals. ”

Julie D’Ascenzo

“Our robust quality system, deep experience, and successful track record are a few reasons that I have confidence in our team to serve as a beneficial partner to companies of all types and sizes.”

Kate Giannantonio

“It’s exciting to offer new capacity along with end-to-end services like process development, stability, analytical testing, and packaging. Addressing more needs onsite at Lifecore helps simplify challenges for my clients.”
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 20 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.

Reduced
Risk

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.

Deep
Partnerships

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.

Flexible
Capabilities

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.