Regulatory Facilitation

In ACTRIS, our Regulatory team offers expertise and services on regulatory-related matters for Cell, Tissue and Gene Therapy products (CTGTPs) particularly aimed at gap analysis and submission for clinical trial certificate (CTC) and chemistry, manufacturing, and controls (CMC) documentation.

As CTGTP regulations are fast evolving and may be relatively challenging to navigate, we have the relevant experience and connections to enable you to understand both the local and international regulations and guidelines. Customised facilitation can be provided to the unique and novel CTGTPs which you may have.