Cross-Border CDMO & Manufacturing Partnerships

Cross-Border CDMO & Manufacturing Partnerships

When a product is moving toward highly regulated markets – such as the US, Europe, Japan or other key international markets – the real challenge is often not simply “finding a CDMO,” but securing a partner whose facilities, equipment, and quality systems truly match your oral solid, liquid, and injectable manufacturing processes, and whose GMP and quality systems are aligned with the regulatory expectations in those markets.

Leveraging extensive hands-on experience across APIs, solid oral dosage forms, liquid formulations, and sterile injectable products, Apexray helps clients identify and build long-term partnerships with international CDMOs whose capabilities align with the required dosage forms and regulatory pathways. We support the entire process – from defining technical and regulatory requirements, through to structuring and securing a CDMO partnership that fits your needs, and negotiating and finalizing MSA/SOW agreements.

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