Scientific Consulting & Regulatory Expertise

Strategic guidance for vaccine and drug development programmes
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Introduction

Accelerating drug and vaccine development requires more than great science—it demands strategic planning and regulatory expertise. Our scientific consulting services help you navigate complex challenges in infectious disease, cardiometabolic disorders, and vaccine development. From early-stage design to global regulatory submissions, we provide integrated solutions that reduce risk and speed time-to-market.

Our Services

  • Regulatory strategy and submissions (IND, CTA, NDA) for vaccines, infectious disease, and cardiometabolic therapies

  • Scientific consulting for study design and development planning

  • Gap analysis and compliance audits aligned with FDA, EMA, and ICH guidelines

  • Translational strategy and biomarker guidance for infectious disease and cardiometabolic programs

Why It Matters

Scientific and regulatory consulting ensures your development program is optimised for success. By integrating regulatory strategy with scientific insight, we help reduce delays, avoid costly missteps, and improve the likelihood of approval. Our expertise in vaccines, infectious disease, and cardiometabolic conditions positions us as a trusted partner for complex programs.

Compliance & Expertise

We align all strategies with global regulatory standards, including FDA, EMA, and ICH guidelines. Our team brings deep experience in regulatory submissions, scientific planning, and translational research to support your program from concept to clinic.

Benefits

  • Reduced risk of regulatory delays and non-compliance

  • Expert guidance for complex therapeutic areas including vaccines and infectious disease

  • Integrated scientific and regulatory approach for cardiometabolic programs

  • Accelerated timelines through strategic planning and modelling

Workflow Overview

  • Consultation & Needs Assessment

  • Regulatory Strategy Development

  • Scientific Planning & Translational Guidance

  • Documentation & Submission Support

FAQ

Get in touch with us
Our scientific consulting services provide expert guidance across all stages of drug development, from early strategy and study design through to clinical execution and data interpretation. We work closely with sponsors to address scientific challenges, optimise development plans, and support informed, evidence‑based decision‑making.
We provide regulatory expertise to support the preparation of regulatory documentation and strategic approaches for engagements with global health authorities. This includes guidance on regulatory strategy, scientific rationale, and data presentation to help sponsors navigate regulatory expectations with confidence.
Yes. Our scientific consulting and regulatory expertise are fully integrated with our laboratory and clinical capabilities. This joined‑up approach ensures consistency between strategy, study execution, and regulatory deliverables, helping to streamline development programmes and reduce risk.

Research & Articles

View all Resources
BlogHuman challenge trialsInfectious diseasesRespiratory viruses

From RSV to hMPV: Building the Next Generation of Respiratory Challenge Models

Andrew Catchpole
Andrew Catchpole Chief Scientific Officer
10 Apr 2026 7 min read
View
BlogLaboratoryHuman challenge trialsInfectious diseasesRespiratory viruses

Controlled Human Infection Model's (CHIM) in your backpack: how Human Challenge Trials support regulatory approval of travel vaccines

Andrew Catchpole
Andrew Catchpole Chief Scientific Officer
10 Apr 2026 5 min read
View
BlogHuman challenge trialsTrial designInfectious diseasesRespiratory viruses

Unravelling the hMPV Surge: From Media Attention to Vaccine Development

Andrew Catchpole
Andrew Catchpole Chief Scientific Officer
10 Apr 2026 6 min read
View

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