Regulatory Affairs For Clinical Trials
End to end regulatory affairs services: regulatory operations, submissions and package writing from CTA/IND and beyond.
- End to end support: regulatory consultancy, operations submissions & agency engagement, and regulatory writing aligned to ICH GCP.
- Lifecycle coverage: before, during, and after trials — from CTA/IND packs, Investigator Brochures, Investigational Medicinal Product Dossiers, Protocol, to interim safety updates (e.g. DSUR), and clinical study reports (including lay summaries).
- Integrated within a full service early phase CRO spanning clinical operations, biometry, medical writing, laboratory (BSL 2/3), and specialised human challenge studies.
- Strategic advantage: early regulatory strategy de-risks programmes, accelerates timelines and unlocks expedited pathways (e.g., FDA Fast Track, EMA PRIME, Orphan Drug designation) which can transform development trajectories.
Start-ups & Emerging Biotech
Maximise limited runway with pragmatic, Target Product Profile-driven regulatory roadmaps and right-first-time submissions to secure approvals, achieve investor milestones, and unlock designations faster.
Midsize & Specialty Pharma
Scale reliably across multiple programmes/indications with dedicated operational support for modifications and compliant documentation. Our integrated teams handle modification updates, variations, safety reports, ensuring consistent compliance without internal bottlenecks.
Large Pharma & Partners
Why hVIVO?
- Strategic regulatory mindset: We view regulatory not as a checkbox but as a lever for speed and value creation. Engaging early to de-risk, align evidence, and speed milestones.
- Full-service early-phase CRO: Single partner for clinical sites, operations, labs, recruitment, data/biostats, QA, and medical writing; reducing handoffs and risks.
- Human challenge expertise: Integrate challenge models to generate robust early efficacy signals and regulator-aligned endpoints, supported by proactive regulator engagement when it fits your programme.
- Proven, structured delivery: Consistent processes ensure compliant, on-time submissions and timely approvals.
Regulatory Strategy as Competitive Advantage: From Compliance to Acceleration
For many years, regulatory affairs were viewed as a necessary hurdle in drug development. The role was to ensure compliance, prepare dossiers, and shepherd submissions through complex national and international frameworks. That perception is outdated. Today, regulatory strategy is not simply about compliance; it is a source of competitive advantage. When integrated early into drug development planning, regulatory expertise can accelerate timelines, de‑risk programmes, and even enhance the commercial value of a compound. At hVIVO, our regulatory experts have seen this transformation first‑hand. Their experience across early‑phase clinical trials, human challenge studies, and complex therapeutic areas has shown that regulatory affairs are no longer confined to the back room. They are central to shaping development pathways, influencing policy, and ensuring that innovative treatments reach patients more quickly.