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Drug Development Due Diligence Services

hVIVO provides comprehensive technical due diligence services, evaluating drug development assets. Our cross‑functional expertise assesses scientific, CMC, nonclinical, clinical, regulatory, and operational risks to support confident investment, licensing, and acquisition decisions. For startups, we also offer gap analysis (mock due diligence) to prepare for investor/pharma due diligence.

  • 80+ due diligence projects (~150 including gap analysis) delivered in the past years across multiple modalities 
  • Full crossfunctional expertise: CMC, nonclinical, early clinical, regulatory, QA, biometry 
  • Extensive experience supporting investors and pharma through enduring professional relationships 
  • Proven ability to deliver rapid due diligence within tight timelines 

Who This Is For?

Start‑Ups & Early Biotechs

We help validate drug development strategies, identify critical gaps, and strengthen data packages to ensure readiness for investor or pharma due diligence.

Growth‑Stage Biotechs

We assess preclinical and early clinical evidence, supporting go/no‑go decisions.

Pharma, Strategic Investors & Funds

We deliver evidence‑backed risk assessments of asset of your interest to support investment, acquisition, or in‑licensing.

What This Service Is

Technical due diligence is a high-impact evaluation that reveals the true scientific, nonclinical, clinical, operational, manufacturing, and regulatory viability of a drug development asset—helping organisations understand not just what an asset is today, but what it will take to successfully progress it.

By identifying key risks, development gaps, and dependencies early, this service:

  • Empowers investors, pharma teams, and biotechs to make confident go/no-go, investment, licensing, or acquisition decisions. 
  • Helps startups sharpen development program and fortifies the data package, positioning you for successful investor or pharma engagements. 

Our team translates cross-functional findings into actionable risk mitigation plans, mileston-ealigned development strategies, and post-diligence support, helping you move immediately from insight to execution.

Working With hVIVO

Scope Alignment & Set‑Up

Cross‑Functional Scientific Review (CMC, nonclinical, clinical, regulatory etc.)

Presentation of findings with ratings and recommended actions

Final Due Diligence Report

Our Capabilities & Expertise

Our cross-functional teams bring deep expertise across CMC, non-clinical, clinical, regulatory, QA, and biometry, with specialised early phase and challenge model experience spanning small molecules, biologics, ADCs, ATMPs, and combination products.

Cross‑functional teams across CMC, non‑clinical, clinical, regulatory, QA, biometry.

Early‑phase and challenge model expertise.

Experience across small molecules, biologics, ADCs, ATMPs and combination products.

Why hVIVO

  • 80+ due diligence (~150 including gap analysis) projects delivered over past years. 
  • Deep crossfunctional expertise. 
  • Trusted by pharma and global investors. 
  •  Transparent reporting and rigorous scientific integrity. 

FAQs

Yes — we have delivered full crossfunctional diligence in as little as two weeks.

Yes — we provide modular diligence as well as comprehensive reviews.

Yes — our consultants can oversee follow-up activities and milestone delivery.

Absolutely — we frequently support both.

Speak to our Due Diligence Team.

Contact hVIVO

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