Contract Development
& Manufacturing
Tailored Solutions for Every Pharmaceutical Project
At Eirgen Pharma, we recognize that each pharmaceutical project is unique, and we tailor our approach to ensure your success. As a leading Contract Development and Manufacturing Organization, we offer customized drug development and manufacturing solutions designed specifically for your needs.
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Pharmaceutical Development Stages
PREFORMULATION PHASE
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Analysis of bibliographic data
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Review of existing patents
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Exploration of relevant physicochemical properties for candidate drug substances
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Development of target product profile
PROCESS DEVELOPMENT PHASE
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Enhancement of quality by design strategy
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Development of process design space
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Creation and implementation of robust and transferable processes allowing transition from R&D to production scale
FORMULATION DEVELOPMENT
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Initiation of Quality by Design strategy compliant with ICH guidance and market specific regulations
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Development of formulation design space
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Material compatibility studies
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Stable confirmation studies
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Development of analytical methods
SCALE-UP (technology & site transfer activities)
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Effective in-house handling of scale-up tasks
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Minimisation of tech-transfer risks
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Manufacturing process brought from optimisation to validation
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Analytical methods validation
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Quality by Design strategy finilised
FULL SUPPORT OF CLINICAL TRIALS
The Eirgen laboratories fully supports all phases of clinical trials providing:
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Manufacture and release of clinical supplies
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Clinical development strategy and planning
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CRO management and oversight
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Clinical trial application
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Clinical trial stability program
REGULATORY OF STRATEGY & MANAGEMENT OF DRUG DEVELOPMENT
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Provide regulatory advice in the early phases of development projects
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Interpret regulations and guidelines
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Develop strategies for technical aspects of drug development (quality, pre-clinical, and clinical)
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Identify and manage external resources/experts
Your Path to Pharmaceutical Success
At Eirgen Pharma, we understand that every pharmaceutical project has its own unique needs. That's why we offer a customized approach at every stage of development to ensure your success. From the initial concept to full-scale commercialization, we work alongside you, providing expertise, speed, and efficiency that accelerate time-to-market and exceed regulatory requirements.
What We Do For You
How We Deliver
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Accelerated Time-To-Market: Our personalized development strategies are designed to fast-track your product's journey, helping you stay ahead in a competitive market.
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Seamless Transition: We specialize in taking your product from clinical trials to full-scale commercial production, ensuring smooth, uninterrupted scaling.
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Regulatory Confidence: With our in-depth knowledge and experience, we help you navigate regulatory hurdles with ease, ensuring compliance every step of the way.
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Expertise in Investigational Medicinal Products (IMPs): Whether for clinical supply or commercial manufacturing, our proven track record guarantees high-quality results.
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Flexibility with GMP and non-GMP Facilities: Our state-of-the-art facilities cater to all stages of development, offering both GMP and non-GMP solutions, tailored to your specific needs.
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Comprehensive R&D Solutions: We're you're trusted partner throughout the entire lifecycle of drug development, providing seamless integration of R&D at every phase.
Proven Track Record of Successful Pharmaceutical Development
From small-scale non-GMP to GMP clinical batch production, our team ensures the timely and cost-effective delivery of your project. Whether it's API identification or the final clinical product, our CDMO services provide a smooth path through every stage of drug development. A dedicated project manager leads a cross-functional team, working within specialized cell structures to ensure seamless execution and regulatory compliance at every step.