Our regulatory consultants work as an extension of your team, providing timely and expert guidance throughout product development. We help you anticipate regulatory challenges, streamline submissions, and accelerate progression through the regulatory landscape.
End-to-end support across the full product development lifecycle
Expertise interacting with EMA, FDA, MHRA, and EU national authorities
Strategic preparation for designations such as Orphan Drug Designation, PRIME, Breakthrough Therapy
Early clarity on regulatory expectations, efficient planning, and support with first-in-human readiness.
Strategic development planning, gap analysis, and regulatory interactions to derisk milestones.
Robust execution of global regulatory strategies, designation applications, and lifecycle management activities.
hVIVO provides end-to-end regulatory advice throughout product development. Acting as an embedded extension of your team, our consultants offer timely, competent advice that ensures regulatory strategies are executed effectively and without unnecessary delays. We help ensure your product is developed, manufactured, and controlled according to expected standards of quality, safety, and efficacy.
Review of development status, regulatory history, and programme goals.
Creation or refinement of Target Product Profile (TPP) and drug development plans.
Identification of regulatory, data, or documentation gaps that may impact progression.
Preparation for EMA, FDA, MHRA, or EU national authority meetings, including rehearsal, briefing packages, meeting attendance, minutes, and follow-up.
Preparation and submission of Orphan Drug Designation (ODD), Priority medicines (PRIME) designation, Breakthrough Therapy designation (BTD), Qualified Infectious Disease Product (QIPD), advanced medicinal product (ATMP) designation requests, or Innovation Task Force (ITF) dossiers.
Continuous guidance throughout development to prevent delays and support strategic decision making.
Our regulatory consulting services include:
Any stage — from early-stage planning to late-stage regulatory submissions.
Yes. Our consultants have experience engaging with EMA, FDA, MHRA, and European national agencies.
Absolutely. We support briefing packages, rehearsal, attend meetings, prepare meeting minutes, and post-meeting actions.
Yes — including ODD, PRIME, Breakthrough Therapy, QIPD, and ITF requests.
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