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CDMO

CDMO contract development and manufacturing: a Global Top-tier partnership and cGMP verified infrastructure

From Preclinical Development to Commercialization,
We Provide End-to-End CDMO Services.
Flexible solutions tailored to each stage of development, supporting your projects from early development through commercialization.

Global Top-tier
CDMO Partnership

Partnership with a global top-tier CDMO

Based on global infrastructure including Porton,
we deliver the optimal CDMO solution.

Our Strengths & Capabilities

  • Exclusive Partnership with Porton

    Exclusive partnership with Porton, a global top-tier CDMO
    We manage projects locally in Korea and provide access to Porton's proven global manufacturing infrastructure for reliable development and production.

  • Global GMP Infrastructure

    cGMP manufacturing infrastructure aligned with FDA, EMA, and PMDA standards
    Our global-standard manufacturing infrastructure supports projects targeting international markets and regulatory approvals.

  • From KSM development to Drug Product (DP) manufacturing

    We provide end-to-end services covering KSM (Key Starting Material) development under Non-GMP and GMP conditions, customized process development, contract synthesis, and FDF manufacturing.

  • Support at Every Development Stage

    Flexible support from preclinical development to commercialization
    From early-stage material supply and small-scale synthesis to clinical-scale production and continued commercial supply, we provide solutions tailored to each stage of development.

Procedure of CDMO

Raw Material to DP

We provide end-to-end CDMO services, from KSM development to finished dosage form (FDF) manufacturing.

  1. KSM Development & Supply

    • We develop and supply Key Starting Materials (KSMs) in accordance with Non-GMP and GMP requirements.

  2. Customized Process Development

    • We develop processes tailored to target formulations and quality requirements, with flexible support based on the development stage and project needs.

  3. Contract Synthesis & Manufacturing

    • We support contract synthesis of a wide range of compounds, including complex molecules, through proven manufacturing infrastructure.
    • Access to Porton's cGMP manufacturing infrastructure aligned with FDA, EMA, and PMDA standards

  4. DP Manufacturing

    • We provide integrated CDMO services extending from raw material and intermediate development through Drug Product (DP) manufacturing.
A researcher checking a sample under a microscope
  1. Dedicated CDMO
    inquiry intake
  2. KSM development(Key starting material)
  3. Custom process development
  4. Contract synthesis
  5. Finished dosage form (FDF)
    contract manufacturing

Scope of support by development stage

Preclinical

  • Securing early materials
  • Small-scale synthesis

Solution

  • KSM (Key starting material) developmentStarting material developed and supplied at Non-GMP · GMP level
  • Custom process developmentProcess designed for the target dosage form and specification

Phase 1 · 2 · 3

  • Stabilizing the process while scaling up
  • Process validation for commercial production

Solution

  • Contract synthesisEven demanding compounds synthesized on verified facilities
  • cGMP verified infrastructureInfrastructure that has passed FDA · EMA · PMDA verification

Commercialization

  • A continuous supply system aligned with approved specifications

Solution

  • Finished dosage form (FDF) contract manufacturingConnected in one flow through finished production
  • Support for overseas expansionContract manufacturing for Korean pharmaceutical and bio companies expanding abroad

CDMO projects,
from early design through approval to mass production,
solved in one stop.

Tell us the development goal you have in mind,
and our team will reply promptly

CDMO Inquiry
A researcher in cleanroom apparel checking records