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
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 Pharma Services 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 37+ years of experience to help you solve your development and supply challenges. Learn more about what it means to differentiate your development process with Pyramid Pharma Services.