Cross-Border CDMO & Manufacturing Partnerships

Cross-Border CDMO & Manufacturing Partnerships

When pharmaceutical products move toward highly regulated markets such as Europe, the US, Japan, and other key regions, the challenge is rarely limited to “finding a CDMO.”
It is about assessing whether a facility’s equipment, quality systems truly match the required dosage forms, manufacturing processes, and regulatory expectations in those markets.

This section highlights professional experience accumulated across oral solid dosage forms, liquid dosage forms, and sterile injectable products — including evaluating CDMOs whose equipment/ technical capabilities, GMP standards, and quality systems align with regulatory pathways in Europe, the US, Japan, and Asia Pacific (APAC).

Project experience has included:

• Reviewing CDMO manufacturing capabilities for solid, liquid, and injectable dosage forms.

• Assessing GMP alignment, quality-system maturity, and equipment/ technical fit for intended markets.

• Supporting internal teams in preparing for partner selection and regulatory pathway planning.

• Coordinating technical, quality, and commercial viewpoints to secure long-term, compliant manufacturing solutions.

Contact

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