Our Services
Clinical Trial Regulatory Affairs Services
End-to-end regulatory support across UK, EU and global markets. Focus on the science while we manage submissions.
Regulatory Affairs
What We Deliver
TCR Solutions manages CTA, IND, IMPD and ethics submissions so sponsors can focus on the science.
We handle MHRA Combined Review (CTA) and IRAS submissions, EU CTR submissions via CTIS, and FDA IND preparation and submission support.
Our regulatory team also provides IMPD compilation and lifecycle maintenance, ethics committee and HRA approvals, substantial amendments and annual safety reports — giving you a single point of contact across multiple jurisdictions.
The Value
Why It Matters
Our regulatory expertise delivers first-time approval rates above industry average, reduced clock-stops and RFI cycles, and a single point of contact across multiple jurisdictions.
This means your trial starts on time and stays compliant throughout its lifecycle.
FAQs
Frequently Asked Questions
Do you handle UK Combined Review submissions? Yes — TCR routinely files via MHRA Combined Review and IRAS for UK CTAs.
Can you submit through CTIS? Yes — we support full EU CTR submissions and lifecycle management via CTIS.