The
Process
Our Proven Process: From Molecule to Market
At Eirgen, we provide fully integrated end-to-end development and manufacturing process tailored to bring your pharmaceutical products to life - efficiently, safely, and with full regulatory compliance. Our streamlined process is designed to reduce complexity, accelerate timelines, and deliver quality at every stage.
The Eirgen Process
Discovery & Feasibility
We start with an in-depth consultation to understand your molecule and project goals. Feasibility studies assess your compatibility, scalability, and regulatory considerations.
Pre-Formulation & Formulation Development
Our formulation experts develop robust, scalable dosage forms, including highly potent and non-potent oral solid doses. We apply Quality by Design principles to ensure accuracy, consistency, and compliance.
Process Development & Optimization
We translate lab-scale formulations to GMP-compliant processes. Our team leverages lean manufacturing principles and cutting-edge technology to ensure reproducibility and cost-efficiency.
Clinical Trial Material Management (CTM)
Eirgen supports early-stage clinical trials by manufacturing clinical batches under strict GMP conditions, with full traceability and documentation.
Scale-Up & Validation
As your product progresses, our technical team ensures seamless scale-up to commercial volumes, supported by rigorous process validation and risk management protocols.
Commercial Manufacturing & Packaging
Our FDA and EMA approved facilities handle global supply demands. We specialize in high-volume, high-containment commercial manufacturing, along with customized packaging solutions.
Regulatory Support & Submission
Our regulatory affairs team assist with CMC documentation, dossier compilation, and global submissions. We stay ahead of evolving requirements across all major markets.
Product Release & Distribution
Final product is release by our QP (Qualified Person) and shipped globally, supported by temperature-controlled logistics and serialization capabilites.
What Sets Eirgen Apart?
High-Potency Capabilities
We specialize in high-containment manufacturing of HPAPI's and cytotoxic compounds. Our facilities are designed for safe handling of highly potent drugs at all scales.
Global Regulatory Expertise
Eirgen has a proven track record of regulatory approvals from the FDA, EMA, HPRA, and other agencies. We navigate global requirements with precision and agility.
Integrated Services
From molecule development to finished dose packaging, we offer a true "one-form" approach. Our seamless integration minimizes handoffs, delays and costs.
Customer-Centric Focus
Our process isn't just technical - its personal. We work as a true extension of your team, building long-term partnerships based on trust, transparency, and shared success.
Adapt. Innovate. Deliver.
At Eirgen Pharma, we understand that pharmaceutical drug development rarely follows a straight line. Over the past 20 years, we have earned our reputation as a global CDMO/CMO by embracing unpredictability with agility, innovation, and precision.
Unexpected challenges - be it formulation, scale-up, or tech transfer - are met with flexible GMP manufacturing processes tailored to overcome obstacles and reduce time-to-market delays. Our team works collaboratively to de-risk your program and ensure your clinical and commercial milestones are met.
Once your next target is defined, you can count on us to adapt our approach, optimize production, and deliver results. This adaptability isn't just a capability - it's our commitment. And it's why leading pharmaceutical companies choose Eirgen as their trusted CDMO partner.
We Get It Right The First Time
Our deep industry knowledge and two decades of experience have earned us a flawless track record for delivering high-quality, GMP-compliant pharmaceutical products - on time, every time.
Whether you're seeking small-batch clinical trial manufacturing or large-scale commercial production, we uphold the highest standards across every phase of your product's lifecycle, from formulation development to manufacturing and packaging.
Our facilities operate with a commitment to;
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Lean pharmaceutical manufacturing to minimize waste
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Regulatory-compliant processes aligned with global standards (EU-GMP, US FDA)
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Cost-effective supply chain management to reduce project costs and increase efficiency
Eirgen's reputation as a leading CDMO and CMO partner is built on excellence, accountability, and the dedication of every team member. We take pride in our motto:
"We get it right the first time - every time."
"Eirgen provided not just manufacturing support but strategic insights across development and regulatory planning. Their team was instrumental in getting our oncology product to clinical trails on time and on budget."
Technology Driven Innovation
Our team embraces digital transformation and innovation - from advanced analytics to process automation. We invest in technology that accelerates development while ensuring top-tier quality and compliance.
Real-Time Data Monitoring
In-Process Control Systems
Predictive Quality Tools
Advanced Containment Technologies