Our Business Development Team
“I’m proud to bring my industry experience to the table for the benefit of my customers. Starting off by building a strong, transparent relationship is essential for reaching common goals to enable each program’s success.”
Mary Evelyn Hudson
“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.”
Julie D’Ascenzo
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
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.
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.
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.