Regulatory Affairs Consulting

Pharmaceutical and biologics regulatory strategy, submissions and agency interactions across the MHRA, EMA and FDA
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Pharmaceutical and Biologics Regulatory Affairs

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.
Consultancy

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Who Our Regulatory Consultants Support

Start-ups

Early clarity on regulatory expectations, efficient planning, and support with first‑in‑human readiness. 

Biotechs

Strategic development planning, gap analysis, and regulatory interactions to de risk milestones. 

Mid/Large Pharma

Robust execution of global regulatory strategies, designation applications, and lifecycle management activities. 

hVIVO_Regulatory_CMC_Services

What This Service Is

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.

 

How Our Regulatory Consultants Work With You

Initial assessment

Review of development status, regulatory history, and programme goals.

 

Regulatory strategy development

Creation or refinement of Target Product Profile (TPP) and drug development plans.

Gap analysis & due diligence

 Identification of regulatory, data, or documentation gaps that may impact progression.

Agency interaction planning

Preparation for EMA, FDA, MHRA, or EU national authority meetings, including rehearsal, briefing packages, meeting attendance, minutes, and follow‑up.

Designation application support

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.

Ongoing consulting

 Continuous guidance throughout development to prevent delays and support strategic decision‑making.

Regulatory Affairs Consulting Services

  • Development of regulatory strategy, including TPPs and drug development plans.
  • Regulatory due diligence and comprehensive gap analysis.
  • Planning and execution of interactions with EMA, FDA, MHRA, and EU national health authorities.
  • Meeting rehearsal, preparation of meeting minutes, and follow up actions.
  • Orphan Drug Designation (ODD) applications.
  • Special designation support including: EMA’s Innovation Task Force, EMA PRIME, FDA Breakthrough Therapy, FDA QIDP (Qualified Infectious Disease Product)
Featured Article

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.

Vi Stuart Regulatory Affairs Consultant.
8 min read
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FAQ

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. 

Phoenix WinNonLin® and SAS®.

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