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Quality & Compliance

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:

  • Drugs
  • Biologics
  • Medical Devices
  • Combination Products
  • API & Excipient for Sodium Hyaluronate
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

Featured Content

Two Lifecore scientists discussing results in a quality control lab

Building Phase-Appropriate Quality from Preclinical to Commercial

FDA Group Videocast

EVP of Quality & Comm. Dev. Jackie Klecker explains how disciplined knowledge transfer, risk management, and communication prevent costly delays as products scale.

Gloved scientist in a face mask holding a vial of injectable drug product

High-Throughput Sterile Filtration of Highly Viscous Pharmaceutical Formulations

Lifecore Article

Learn how Lifecore overcomes the challenge of sterile filtration of viscous formulations with a unique approach.

High-Throughput Sterile Filtration of Highly Viscous Pharmaceutical Formulations

Lifecore Technical Article

Learn how Lifecore overcomes the challenge of sterile filtration of viscous formulations with a unique approach.

Tackling Complex Manufacturing through Technical Grit

PharmaSource Audio Podcast

Lifecore’s team shares how we’ve tackled complex process development & manufacturing challenges.