Clinical
Manufacturing
Services
At Eirgen Pharma, we specialize in delivering tailored scientific and clinical development solutions for Value-Added Medicines (VAM) and generic pharmaceutical products. Our experienced team provides strategic guidance, hands-on project management, and personalized support to help clients navigate the complexities of clinical development with clarity and confidence.
Collaborative End-To-End Clinical Support
We work closely with a trusted network of leading Clinical Research Organisation's (CROs) and subject matter experts to implement efficient, compliant clinical strategies. From study design to regulatory navigation, our services are designed to accelerate development timelines while ensuring scientific rigor and regulatory alignment.
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With a track record of successful bioequivalence studies, Eirgen brings deep insight and proven methodologies to each project - ensuring our clients are supported at every stage of the clinical journey.
Our Clinical Development Services
Clinical Strategy & Program Design
Tailored clinical roadmaps for generic and value-added formulations
Bioequivalence Study Expertise
With numerous studies completed, we ensure regulatory-compliant, high-quality outcomes
BSC-Based Biowaivers & IVIVC
Leverage scientific modelling to reduce time and resource requirements
Advanced Dissolution Analysis
Including bootstrapping and model-dependent/independent approaches
Clinical Trial Oversight
From protocol development to final reporting, guided by experienced project managers
Scientific Advice & Global Regulatory Interfacing
Preparation for EMA, FDA, and other health authority engagements
Regulatory Dossier Support
Nonclinical and clinical overview authoring and documentation review
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Over the 20 years of pharmaceutical development excellence​
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Deep experience across therapeutic categories and dosage complexities
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Integrated development and GMP clinical manufacturing on one campus
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Flexible, responsive partnerships model with global reach
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Commitment to quality, speed, and science-led decision-making
