(1) Regulatory Compliance Services ● Market Access Certifications: Assist with target market approvals (FDA/CE, etc.). ● Product Registration & Documentation: Prepare regulatory submission documents and offer pre-audit support and compliance advi...
(1) Regulatory Compliance Services
● Market Access Certifications: Assist with target market approvals (FDA/CE, etc.).
● Product Registration & Documentation: Prepare regulatory submission documents and offer pre-audit support and compliance advisory services for suppliers.
● Regulatory Monitoring: Continuously track updates to target market regulations and provide compliance guidance to suppliers and partners.
(2) Production Process Optimization
● Evaluate production processes during supplier selections and offer professional recommendations.
● Provide technical support to clients for iterative upgrades in product manufacturing technologies.
(3) Contract Development & Manufacturing (CDMO/CMO)
● CDMO:
· End-to-end services from process development, pilot-scale production, to commercialization.
● CMO:
· Scale-up production of client-developed products and ensure seamless technology transfer.
● Facility Compliance:
· cGMP-compliant manufacturing facilities and quality management systems.
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