Regulatory Facilitation
ACTRIS provides regulatory support for cell, tissue, and gene therapy products, guiding clients through key regulatory milestones from gap assessment and development planning to clinical trial submissions.
ACTRIS provides regulatory facilitation services for cell, tissue, and gene therapy products (CTGTPs), supporting clients in navigating evolving regulatory requirements throughout the product development lifecycle.
Our team offers expertise in regulatory gap assessments, regulatory strategy, and the preparation of documentation required for clinical trial applications (CTAs), chemistry, manufacturing and controls (CMC) submissions, and other regulatory engagements. Leveraging experience with both local and international regulatory frameworks, ACTRIS helps clients address product-specific regulatory considerations and development challenges.
Recognising that each CTGTP presents unique characteristics and requirements, ACTRIS provides tailored regulatory support to facilitate efficient product development and regulatory compliance.
Regulatory Affairs Lifecycle
The regulatory affairs lifecycle encompasses regulatory planning, data and process evaluation, submission preparation, regulatory interactions, and post-submission activities throughout product development.
ACTRIS supports these activities through data review and analysis, preparation of regulatory documentation, and guidance on submissions required from early-stage development through to clinical evaluation and manufacturing readiness.
Early regulatory planning helps reduce development risks, minimise rework, and facilitate a more efficient pathway towards clinical translation.