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  • What We Do
    Our Services

    We offer the pharmaceutical and biotech industries a wide range of services for both Clinical and Commercial products.

    Drug Product Development

    Formulation and process development for liquid & lyophilized products

    Lyophilization

    Development and GMP manufacturing for lyophilized drug products

    Clinical Manufacturing

    GMP manufacturing and distribution for clinical trials

    Commercial Manufacturing

    FDA-registered facility currently making products for global distribution

    Biologics & Novel Modalities

    Drug product development and manufacturing for biologics and other novel modalities

    Analytical Services & QC Testing

    Method development, validation and testing

    Stability Studies

    Long-term, accelerated and in-use GMP stability studies

    Quality Assurance & Regulatory Support

    GMP manufacturing, testing and associated processes

    Labeling, Storage & Distribution

    ICH-compliant temperature controlled GMP storage and global distribution

  • How We Help
    Overview

    Pyramid Labs has helped many clients on their journey from early stage all the way to commercial approval.

    Formulation & Development
    Formulation & Development

    Pyramid Labs has a proven track record of helping clients successfully move from clinical stage to commercial approval.

    Clinical Supply
    Clinical Supply

    Pyramid Labs has a proven track record of helping clients successfully move from clinical stage to commercial approval.

    Commercial Production
    Commercial Production

    Pyramid Labs manufacture multiple commercial drug products for distribution to international markets.

  • About Us
    Who We Are

    We deliver the highest quality from early-stage development through commercial production.

    Our Expert Team

    Our accomplished team brings expertise in formulation, testing, and manufacturing — ensuring top-quality services.

    Work At Pyramid

    Join us in shaping the future of drug development and manufacturing, one breakthrough at a time.

  • News & Events
    News
    Upcoming Events
Contact us

Commercial Manufacturing

With our track record of commercial drug product manufacturing in the US, Canada, EU, Japan and beyond, we understand the nuances of international regulatory requirements. Our experts can prepare you fully for the successful entry of our product into markets across the globe.

 

OUR CAPABILITIES

Our Commercial Manufacturing Know-How—for Your Peace of Mind

Whether your product is on the path to approval or has been on the market for years, we can enhance the value and security of your commercial supply chain. We’ve assisted numerous clients in achieving successful commercial approval across multiple international markets.

  • Extensive experience with FDA inspections, QP inspections, mock inspections, commercial audits and international regulatory approval processes
  • 100% weight check vial filling for liquid and lyophilized drug products
  • Filling of prefilled syringes for health care settings and home use
  • Commercial packaging & labeling
  • Commercial production of approved products for markets in the US, Canada, EU, Japan, Australia and beyond

Contact Our Experts

OUR PROCESS

Commercial Drug Product Manufacturing for International Markets

01

PPQ to Approval

We can design and execute PPQs and PV studies to support your NDA submission. Our quality and regulatory staff have extensive experience supporting clients through the pre-approval inspection and approval process.

02

Storage & Distribution

Our controlled access and video-monitored labeling and packaging suites are adjacent to controlled-temperature storage for seamless transfer between areas before shipment to your global markets.

03

Commercial Track Record

Since our inaugural commercial manufacturing run in 2015, we have built a solid track record for vial and prefilled syringe filling of several commercial products intended for global markets.

OUR FACILITIES

Liquid or Lyo, Vial or Syringe

For over 20 years, Pyramid Labs has been a cornerstone in clinical manufacturing. Whether it’s liquid or lyophilized, vial or syringe, we can scale our capabilities to align with the needs of your clinical program. Our facilities boast advanced equipment, including a 100% weight check IMA vial filler, Cozzoli syringe filler and a state-of-the-art Telstar lyophilizer.

Related Services

Lyophilization

Development and GMP manufacturing for lyophilized drug products

Clinical Manufacturing

GMP manufacturing & distribution for clinical trials

Labeling, Storage 
& Distribution

ICH-compliant GMP storage. Global distribution

How Can We Help?

Let us apply our 36+ years of experience to help you solve your drug development and supply challenges. Learn more about what it means to differentiate your development process with Pyramid Labs.

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A trusted drug development and manufacturing partner, 37 years and counting.
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