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.

Regulatory Affair Life Cycle

The Regulatory Affair Lifecycle would include data and process analysis, regulatory submission, follow-ups, approvals which eventually lead to clinical evaluation/trials, commercialization and/or marketing.

Regulatory submission would involve submission of documents and records from the initial stages of process development, right up to manufacturing of the final product.

With ACTRIS managing your project from the initial stages, we would be able to reduce both time and rework in your regulatory affair life cycle thus making the process both time and cost-effective.