Drug Development Due Diligence and Gap Analysis Services

hVIVO provides independent, cross-functional technical due diligence for drug development assets - assessing scientific, CMC, nonclinical, clinical, regulatory, and operational risk to support confident investment, licensing, and acquisition decisions.

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What This Service Is

Technical due diligence reveals the true scientific, CMC, nonclinical, clinical, regulatory, and operational viability of a drug development asset — not just what it is today, but what it will take to successfully progress it.

Because so much rides on getting this right, our review is independent and cross-functional: rather than relying on a single specialist's view, our team examines an asset from every angle that could affect its outcome, so decisions are based on a complete picture rather than partial evidence.

By identifying key risks, development gaps, and dependencies early, this service adapts to where you sit — see who we work with below.

Who We Work With

Start-Ups

Through gap analysis (mock due diligence), we help start-ups validate development strategies, identify critical gaps, and strengthen data packages — so you're ready before an investor or pharma partner starts asking hard questions.

More for Start-Ups

Biotechs

We assess pre-clinical and early clinical evidence across your pipeline, applying the same cross-functional rigour we bring to external deals — giving you an independent read to support confident internal go/no-go decisions.

More for Biotech

Investors & Pharma

We deliver evidence-backed risk assessments of the assets you're evaluating — covering scientific, CMC, nonclinical, clinical, and regulatory risk — so you can move forward on investment, acquisition, or in-licensing decisions with confidence.

More for Pharma

Need more than a risk report?

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

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Proven Due Diligence Expertise

hVIVO has completed 80+ due diligence projects (150+ including gap analysis) for investors, pharma companies, and biotechs evaluating drug development assets. Our cross-functional team draws on deep expertise across CMC, non-clinical development, clinical, and regulatory affairs to assess risk from every angle, with full evaluations delivered in as little as two weeks.

This same expertise underpins our work with drug development investors evaluating a potential deal, and our gap analysis support for start-ups preparing for investor or pharma scrutiny.

80+

Due diligence projects delivered (150+ including gap analysis)

2 wks

Fastest turnaround for a full cross-functional evaluation

Disciplines assessed in every review (scientific, CMC, nonclinical, clinical, regulatory operational)

Modalities covered (small molecules, biologics, ADCs, ATMPs, combination products)

25+ years

authoring drug development plans

Due Diligence Framework

CMC

We assess whether the manufacturing process is robust, scalable, and ready to support later-stage development — including analytical method validation, the stability data package, and impurity profile consistency across batches. We also look at supply chain and CDMO readiness, since a strong asset can still stall if manufacturing capacity or continuity isn't secured.

Non-Clinical

We review the completeness of the toxicology program and PK/ADME characterisation, checking that species selection supports genuine translatability to humans rather than just regulatory box-ticking. GLP compliance status is assessed throughout, since gaps here can force costly repeat studies later in development.

Clinical

We evaluate whether study designs, endpoint selection, and biomarker strategy are appropriate for the asset's stage and indication, not just scientifically defensible in isolation. Safety database adequacy and the rationale behind dose-finding decisions are reviewed to confirm the clinical story holds up under scrutiny.

Regulatory

We assess alignment with FDA, EMA, and MHRA expectations, IND/CTA readiness, and eligibility for expedited designations such as Fast Track or PRIME. Just as importantly, we look at whether the regulatory roadmap itself is clear enough for an investor or partner to understand the path — and the cost — ahead.

We review GxP compliance across the full development chain, along with audit history and any findings that could signal deeper quality system issues. Quality system maturity is assessed as a leading indicator of how reliably the asset's data package will hold up to future scrutiny.

Biometry

We assess the robustness of statistical analysis plans and the integrity of the underlying data, since weaknesses here can undermine even a strong clinical result. We also look at whether biostatistics resourcing is adequate for the pivotal studies ahead, not just the studies already completed.

Working with hVIVO

Scope Alignment & Set‑Up

We ensure full clarity on objectives, data access, timelines, and risk priorities — so the diligence approach is precisely tailored to your asset and strategic needs. Whether you need a rapid two-week assessment or a deeper, multi-disciplinary review, we agree the right scope and team upfront, including which specialists your asset actually requires.

Cross‑Functional Scientific Review

We conduct an integrated deep-dive across CMC, nonclinical, clinical, and regulatory disciplines — surfacing hidden risks, development gaps, and dependencies that influence asset viability. Our team reviews the asset together rather than in isolation, drawing on additional QA and biometry expertise and experience across small molecules, biologics, ADCs, ATMPs, and combination products, so nothing that could affect its progression gets assessed in a silo.

Presentation of findings with ratings and recommended actions

We present a clear, prioritised view of risk levels and actionable next steps — enabling rapid internal alignment and confident decision-making. Findings are rated, not just listed, so what matters most is immediately clear and your team can move from insight to internal sign-off without re-interpreting the data yourselves.

Final Due Diligence Report

We deliver a concise, decision-ready report that captures cross-functional insights, risk assessments, and strategic recommendations — supporting investment or progression. Beyond the report itself, we're on hand to help translate findings into next steps, whether that's supporting a go/no-go decision, informing an investment or licensing decision, or shaping the development plan that follows.

Meet our Due Diligence team

Every due diligence review is led by senior specialists who own their discipline day-to-day, not a generalist team assembled for the occasion. Meet the people behind our cross-functional assessments:

Case Studies

Expedited Due Diligence for a Biotech Investor

Our rapid, two‑week diligence provided the depth and clarity needed for swift investor decision‑making, reinforcing hVIVO Consulting as a trusted partner for time‑sensitive evaluations

In‑Licensing Due Diligence for Global Pharma

Our Drug Product assessment provided the clarity and risk visibility needed for a confident in‑licensing decision—so impactful that it led to an expanded, ongoing partnership with the global pharma team

Featured Blog

Understanding Due Diligence in Drug Development for Startups

What is Due Diligence? Due diligence is a thorough investigation and evaluation of an asset before finalizing an investment, partnership, or acquisition. It is one of the last and essential steps before a formal investment is committed. The process ensures that there are no hidden issues or risks that could affect the investment's success. In the (bio-)pharmaceutical sector, due diligence encompasses a multi-dimensional assessment of scientific, regulatory, financial, and legal parameters to identify and quantify material risks and opportunities. This process is particularly critical in drug development, where the complexity and uncertainty of clinical and commercial outcomes necessitate rigorous scrutiny. For investors and acquirers, due diligence validates the scientific merit, developmental feasibility, and commercial potential of a therapeutic asset, reducing the risk of investing in suboptimal or non-viable technologies. For startups and scaleups, the due diligence process is an opportunity to demonstrate the robustness of their development strategy, the integrity of their data, and the scalability of their operations. A successful due diligence outcome can facilitate fundraising, licensing agreements, or acquisition deals. Key Focus Areas in Drug Development Due Diligence Due diligence in drug development typically spans several domains. Scientific and clinical due diligence evaluates robustness of non-clinical and clinical data, including non-clinical safety/efficacy observations and their translation into a clinical setting. Chemistry, Manufacturing, and Controls (CMC) assessments focus on manufacturing processes, formulation stability, and scalability. Regulatory reviews involve regulatory strategies and prior correspondence with regulatory agency (FDA/EMA). The Role of Mock Due Diligence Mock due diligence, or gap analysis, is a simulated third-party review that identifies deficiencies or risks before formal investor or partner evaluations in advance. For emerging biotechs, this step is indispensable. It highlights potential red flags, such as. insufficiently developed analytical methods or inconsistent impurity profiles between GLP and clinical batches, allowing companies to address issues proactively. Although mock due diligence does not guarantee a term sheet or investment, it significantly enhances the probability of a favorable outcome. It also provides founders with insights into how their assets will be perceived by external stakeholders. Demonstrating transparency, technical competence, and strategic foresight during this process builds trust with potential investors. Expertise in Drug Development Due Diligence hVIVO's consultancy offers specialised consultancy services in drug development due diligence, with a focus on CMC, non-clinical and early clinical development, regulatory strategy, quality assurance, as well as health technology assessment via an external partner. Over the years, our team has conducted more than 100 due diligence and gap analysis projects across a wide spectrum of therapeutic modalities, including small molecules, biologics, antibody-drug conjugates (ADCs), advanced therapy medicinal products (ATMPs), drug-device combination products, and gene therapies. These projects have supported decision-making for investors (including several renowned life-science investors), pharmaceutical companies, and biotech startups. Experts in Action Our consultants supported a biotech developing a combination product (ATMP + medical device) by conducting a gap analysis involving all necessary disciplines. This review uncovered a large hiccup in regulatory roadmap, which is considered critical for coming a meeting with investors. Therefore, we advised and helped set a regulatory strategy and associated actions to proactively address the foreseeable issues. This proactive approach enabled the biotech company to secure a term sheet, illustrating how the gap analysis prior to the due diligence can directly influence investment and partnership success. In Summary In drug development ‘s high-stakes environment, due diligence is more than a procedural requirement: it is a strategic imperative. Venn exemplifies the value of integrated due diligence support, combining deep domain expertise with a holistic understanding of the drug development lifecycle. Their track record across diverse modalities and development stages underscores the importance of early, informed, and strategic planning in the pursuit of therapeutic innovation. On-demand Webinar Want to learn more? Watch our webinar, featuring three experts: Erik Gout (left, Head of CMC), Arthur Noach (middle: Senior Consultant Non-Clinical Expert) and Katsuhiro Mihara (right, Head of Clinical Development). Please register to for on-demand access : Mastering Technical Due Diligence: What Every Startup Founder Needs to Know - hVIVO

Katsu Mihara Head of Clinical Development & PK/PB

5 min read

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FAQs

Can you support a very short diligence timeline?

Yes — we've delivered full cross-functional diligence, across CMC, non-clinical, clinical, and regulatory disciplines, in as little as two weeks. Timelines are agreed upfront during scope alignment, so if your deal or investment decision is time-sensitive, we tailor the review depth and team size to match — without compromising on the breadth of expertise involved.

Do you offer discipline specific diligence (e.g., CMC only)?

Yes — due diligence doesn't have to be all-or-nothing. If you've already identified a specific area of concern, or only need assurance on one part of an asset's profile, we can scope a focused review around a single discipline — CMC, non-clinical, clinical, regulatory, QA, or biometry — rather than a full cross-functional engagement, giving you the flexibility to match the review to what you actually need to know.

Do you support post-diligence implementation?

Yes — the findings don't stop at the report. We translate cross-functional findings into actionable risk-mitigation plans and milestone-aligned development strategies, and our consultants can stay engaged to oversee follow-up activities and milestone delivery, helping you move directly from insight to execution rather than starting that work from scratch internally.

Can you work directly with investors or pharma BD teams?

Absolutely — we work directly with venture capital firms, private equity investors, corporate venture arms, family offices, and pharma business development teams throughout the investment or licensing process, not just at the point of a single review. Our evaluations are independent and science-led, giving investors and BD teams an objective view of an asset's risk to support go/no-go, licensing, or acquisition decisions.

What drug modalities do you have experience with?

We've conducted due diligence and gap analysis across a broad range of modalities, including small molecules, biologics, ADCs, ATMPs, and combination products — so whatever your asset type, our review is grounded in relevant, hands-on experience rather than a generic checklist.

Do you offer gap analysis for start-ups preparing for investor due diligence?

Yes — this is a dedicated part of our service for start-ups and emerging biotechs. Gap analysis (mock due diligence) applies the same cross-functional review used in real investor and pharma evaluations, so you can identify and fix critical gaps in your development strategy or data package before you're formally assessed.