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Contract Development 
& Manufacturing

Fast, Flexible CDMO Services for Pharma and Veterinary Products

At Eirgen Pharma, our CDMO services provide fully integrated pharmaceutical development and manufacturing solutions, tailored to meet the unique needs of both human and veterinary medicine partners worldwide. From pre-formulation to commercial supply, we combine scientific expertise with flexible manufacturing capabilities to accelerate your product's time-to-market. 

Pharmaceutical Development Stages

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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

Trusted to Deliver, Built to Excel

Our Promise To You

Speed-To-Market - Fast project initiation, short decision cycles, and streamlined tech transfers.

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Flexible Formulation Development - Adaptable approach to meet evolving clinical and commercial needs.

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Rapid Clinical Supply - Quick GMP batch  production to support early-phase trials.

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Agile Scaling - Seamless transition from clinical to commercial scale without production delays. 

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Fast Regulatory Navigation -  Accelerated support to keep your approval timelines on track.

Contract Drug Manufacturing

Specialized Pharmaceutical CDMO Services for Human and Veterinary Health

Eirgen Pharma provides specialized CDMO solutions for high-potency oral solid dose development - from early formulation to GMP clinical batch production. Our expert teams ensure a seamless, compliant path from API selection to final clinical product. 

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Each project is led by a dedicated project manager and support by a cross-functional team, operating in high-containment environments that meet global regulatory standards.

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Agility is our edge. We move quickly, safely, and in full compliance.

Partner with Eirgen for Smarter CDMO Solutions

Intelligent development. Seamless delivery.

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