Capabilities
Regulatory Coordination
Documentation, submission readiness and compliance coordination for regulated industries.
Overview
We coordinate with qualified regulatory experts and help organise the documentation and communication that regulated projects depend on — CMC sections, technical files, compliance mapping and health-authority correspondence. Our General Manager has direct experience of IND-enabling documentation and Asia-Pacific regulatory strategy.
Deliverables
- TFDA & CDSCO submission coordination
- ISO 13485 documentation support
- REACH & ZDHC Level 3 chemical compliance
- CMC documentation & regulatory writing
- Technical file preparation
- Compliance gap assessment
TFDACDSCOISO 13485REACHZDHC
Have a technology, a supplier need, or a market to enter?
A first conversation costs nothing and usually clarifies more than a month of email.