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Contract Development 
& Manufacturing

Contract Development &Manufacturing
Organisation 

At Eirgen Pharma, we understand that every pharmaceutical project is unique, requiring a personalized approach to thrive. As a leading CDMO, we ensure a customized drug development and manufacturing solution for our partner. Our expertise includes devising product-specific development strategies to accelerate time-to-market, helping you meet project goals and regulatory requirements efficiently. 

We specialize in the manufacturing and packaging of Investigational Medicinal Products (IMPs) for clinical supply, seamlessly transitioning to full-scale commercial manufacturing. With both GMP and non-GMP facilities onsite, Eirgen Pharma offers a range of R&D solutions throughout all phases of the drug development lifecycle.​

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PREFORMULATION PHASE 

  • Analysis of bibliographic data

  • Review of existing patents

  • Exploration of relevant physicochemical properties for candidate drug substances

  • Development of target product profile

PROCESS DEVELOPMENT PHASE

  • Enhancement of quality by design strategy

  • Development of process design space

  • Creation and implementation of robust and transferable processes allowing transition from R&D to production scale

FORMULATION DEVELOPMENT

  • Initiation of Quality by Design strategy compliant with ICH guidance and market specific regulations

  • Development of formulation design space

  • Material compatibility studies

  • Stable confirmation studies

  • Development of analytical methods

SCALE-UP (technology & site transfer activities)

  • Effective in-house handling of scale-up tasks

  • Minimisation of tech-transfer risks

  • Manufacturing process brought from optimisation to validation

  • Analytical methods validation

  • Quality by Design strategy finilised

FULL SUPPORT OF CLINICAL TRIALS
The Eirgen laboratories fully supports all phases of clinical trials providing:

  • Manufacture and release of clinical supplies

  • Clinical development strategy and planning

  • CRO management and oversight

  • Clinical trial application

  • Clinical trial stability program

REGULATORY OF STRATEGY & MANAGEMENT OF DRUG DEVELOPMENT 

  • Provide regulatory advice in the early phases of development projects

  • Interpret regulations and guidelines

  • Develop strategies for technical aspects of drug      development (quality, pre-clinical, and clinical)

  • Identify and manage external resources/experts

PROVEN TRACK RECORD OF SUCCESSFUL PHARMACEUTICAL DEVELOPMENT

From small scale non-GMP to GMP clinical batch production, the Eirgen Pharma team ensures timely and cost-effective delivery of your project. From API identification to the final clinical product, our CDMO services support seamless drug development. A dedicated project manager leads an effective cross-functional team, working within specialized cell structures to ensure smooth execution and regulatory compliance at every stage.

How This Process Benefits Our Partners - 

  1. Creates high-quality, safe manufacturing pathways for teratogenic, cytotoxic, mutagenic, and high bioaccumulation drugs, ensuring compliance with global pharmaceutical standards. 

  2. Develops age-appropriate paediatric formulations for BSV IV renal treatment drug using extended-release (ER) multi-particulate pellets. 

  3. Optimize oncology drug administration with immediate-release (IR) multi- particulates, enteric-coated modified-release systems, and amorphous solid dispersions.

  4. Convert solvent-based processes to direct compression manufacturing for efficiency. 

  5. Develop softgel formulation for a cold-temperature-stable product using advanced pharmaceutical technologies. 

Contract Drug Manufacturing

Eirgen Pharma devises and implements product-specific development strategies capable of delivering high-quality formulations and robust manufacturing processes

Want to learn more about our Contract Development & Manufacturing services? 

Drug blending
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