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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
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:
  • API & Excipient
  • Medical Devices
  • Drug & Combination Products
  • Biologic Products
Routine audits by international authorities have confirmed the robustness of our QMS, leading to an excellent inspection history over many years.
  • 21 CFR 820 (FDA Quality System Regulation)
  • 21 CFR 210, 211 (FDA Good Manufacturing Practice)
  • EudraLex Volume 4 (EU Good Manufacturing Practice)
  • EN ISO 13485, Medical Devices – Quality Management systems – Requirements for regulatory purposes
  • ICH Q7, GMP Guide for Active Pharmaceutical Ingredients
  • Registered FDA Device and Drug Establishment
  • Certified ISO 13485 Quality System (Access certificate)
  • Certificate of Suitability to the Sodium Hyaluronate Monograph of the European Pharmacopoeia
  • European GMP Certification (Access certificate)
  • Japan Foreign Manufacturer Accreditation

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.

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Sodium Hyaluronate

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