The
Process
At Eirgen Pharma, we deliver fully integrated, end-to-end development and manufacturing solutions for high-potency and non-high-potency oral solid dose pharmaceuticals. Our streamlined approach is designed to reduce complexity, accelerate timelines, and ensure quality, safety, and full regulatory compliance at every stage of the product lifecycle.
The Eirgen Process
1. 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.
3. 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.
5. Scale-Up & Validation
As your product progresses, our technical team ensures seamless scale-up to commercial volumes, support by rigorous process validation and risk management protocols.
7. 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.
2. 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.
4. Clinical Trial Material Management (CTM)
Eirgen supports early-stage clinical trials by manufacturing clinical batches under strict GMP conditions, with full traceability and documentation.
6. 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.
8. Product Release & Distribution
Final product is released by our QP (Qualified Person) and shipped globally, supported by temperature-controlled logistics and serialization capabilities.
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 Pharma have 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.
"We Get It Right The First Time - Every Time"
- Eirgen Pharma
Smarter Tech.
Faster Results.
From real-time monitoring to predictive quality tools - we invest in technologies that move your product forward, efficiently, and safely.