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Due Diligence and Asset Evaluation

Make Smarter Biotech Investments with Certainty

Your strategic partner in identifying promising assets and evaluating risks for biotech investments.

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De-risk your investments with data-driven insights and scientific rigor.

In an increasingly competitive and complex landscape, making the right investment decisions has never been more critical or challenging. Promising assets can fail to deliver if risks, regulatory hurdles, or development gaps are not uncovered early. That’s where Certara comes in.

We partner with venture capital, investment, and potential partners to evaluate assets through a multidimensional lens spanning CMC, DMPK, toxicology, regulatory, clinical, and commercial potential. Our mission? To help you find the hidden gems, mitigate risk, and maximize returns by informing your decisions with deep domain expertise and best-in-class tools.

What defines the value of a biopharma asset?

Robust due diligence means assessing more than just early data. Certara helps you evaluate all critical value drivers:

Scientific and clinical strategy

We evaluate the science, therapeutic rationale, and development plan to confirm differentiation and potential for success.

Regulatory and operational readiness

We assess regulatory pathways to identify hurdles early and enable smoother development.

Development and investment risk mitigation

We identify critical scientific, regulatory, and operational risks that could impact asset success, and provide data-driven strategies to mitigate them early and protect your investment.

Commercial potential and market opportunity

Rapid and custom primary research with payers, physicians, and patients to develop evidence-based forecasts.

How Certara supports investment teams

Whether you’re exploring a potential investment or strengthening your next portfolio inflection point, Certara serves as a strategic extension of your team.

Scientific and/or commercial due diligence

We assess data packages, development strategies, model and simulate outcomes, identify risk mitigation strategies, and evaluate commercial potential to guide sound investment decisions.

Strategic landscape mapping

We define regulatory, clinical, and competitive pathways to position your asset for success and differentiation.

Portfolio evaluations

We support companies with expert resources, biosimulation, and tailored strategies to support portfolio review and prioritization.

Tailored support across all development phases

We tailor due diligence and asset evaluation to each stage of development. Whether you’re assessing preclinical potential, aligning Phase 1–2 strategies, preparing for registration, or managing post-market requirements, our experts provide targeted insights to support informed investments and development decisions.

  • Early Phase: Preclinical through First-in-Human (FIH)
  • Mid Phase: Phase 1 and 2 strategy alignment and risk assessment
  • Late Phase: Phase 3 and registration readiness
  • Post-Marketing: Lifecycle management, labeling, and compliance

Certara’s broad expertise across modalities, indications & geographies

Our deep scientific and regulatory insights cover a comprehensive range of drug types and therapeutic areas, enabling tailored support for diverse investment needs:

Integrated strategic early development & bio funding support

Through our Bio Venture Catalyst Solution, we deliver integrated early development strategy, scientific due diligence, and regulatory planning to help VCs identify high-potential assets and accelerate them toward key inflection points—maximizing value creation from day one.

Diverse drug modalities

We bring extensive experience across small molecules, biologics, gene therapies, and cutting-edge RNA-based therapeutics, enabling precise evaluation and development strategies for both traditional and novel modalities.

Wide therapeutic area coverage

Our expertise spans critical and complex indications including oncology, rare diseases, central nervous system (CNS) disorders, infectious diseases, and beyond—providing insight into disease-specific challenges and competitive landscapes.

Global regulatory knowledge

We navigate global regulatory frameworks including the U.S. FDA, European Medicines Agency (EMA), Japan’s PMDA, and China’s NMPA, ensuring that your investment strategies align with region-specific requirements and opportunities.

Comprehensive portfolio and feasibility assessments

From early-stage discovery through late-stage development, we conduct full portfolio evaluations to assess scientific robustness, development feasibility, and market potential, helping you make informed investment decisions.

Scientific and regulatory clarifications

We provide detailed scientific analyses and regulatory guidance to clarify uncertainties, support submission strategies, and accelerate development timelines—reducing risk and enhancing asset value.

Why Partner with Certara?

We help hundreds of biotechs turn big ideas into investor-ready strategies and real outcomes. Schedule a complimentary strategy session with Certara and discover how our integrated expertise can accelerate your drug development, reduce risk, and position you for success.

Schedule a strategy session
155
Biotech companies joined as new Certara clients in 2024
15
Active partnerships with leading VCs and private equity firms for due diligence and portfolio support
90
Certara’s customers have received 90% or more of all novel drug approvals by the FDA from 2014 through 2024
$65B
In value created through licensing deals, IPOs, and acquisitions

Meet our Due Diligence experts

Fran Brown, PhD
1 / 3
Experts

Fran Brown, PhD

Senior Vice President, Certara Drug Development Solutions

Fran has over 25 years of experience with strategic and operational global drug development from early discovery to filing and post-marketing.  She possesses a broad knowledge of strategic drug discovery and development, with a special focus on development strategy and the application of model-informed drug development (MIDD).

Maximilian Vargas, PhD, MBA
2 / 3
Experts

Maximilian Vargas, PhD, MBA

Vice President, Evidence & Access Strategy

Max brings both scientific training and experience in healthcare product development that are important for evidence-based value and access strategies for pipeline and marketed products. Leading a team of analysts and focusing on projects involving late stage, launch, and due diligence efforts, Max’ experience cuts across all major therapeut...

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Colin Callaghan, RPh, MBA
3 / 3
Experts

Colin Callaghan, RPh, MBA

Senior Director, Program Leadership

Colin has 33 years in the pharmaceutical industry primarily in multi-disciplinary drug development leadership roles, including 25 years with early development/early-stage programs.​

At Certara, Colin leads numerous programs in Oncology, CNS, Infectious Disease and Global Health therapeutic areas and supports biotech companies with the...

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Related resources

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Fact Sheet

Certara Strategic Early Development Solutions

A comprehensive guide to optimizing early development strategies.
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2 / 4
Fact Sheet

Strategic Regulatory Affairs

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Fact Sheet

Comprehensive and Customized Toxicology Services

Comprehensive overview of toxicology services.
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Publication

New Horizons of Model Informed Drug Development in Rare Diseases Drug Development

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Contact Certara to de-risk development

Partner with Certara to build an investor-ready, scientifically sound, and strategically aligned early development program. From shaping your foundational roadmap to providing objective due diligence support, our experts deliver integrated solutions that drive smarter decisions, reduce risk, and prepare you for successful fundraising and first-in-human milestones.

155+ biotech companies joined as new Certara clients in 2024
15 active partnerships with leading VCs and private equity firms for due diligence and portfolio support
$65B+ in value created through licensing deals, IPOs, and acquisitions


Frequently asked questions

What makes Certara’s approach to due diligence different from traditional investment evaluations?

Unlike conventional financial or market-only evaluations, Certara conducts multidimensional scientific, regulatory, and clinical due diligence. We go beyond surface-level assessments to uncover risks, identify opportunities, and model development feasibility using best-in-class biosimulation tools and deep subject matter expertise. This helps investment teams make informed, confident decisions earlier in the process.

How does Certara support identifying and advancing high-potential assets?

We partner with your team to evaluate early-stage assets across all critical value drivers, scientific merit, regulatory viability, development timelines, cost assumptions, and commercial opportunity. Our experts join your deal team to assess data packages, conduct modeling and simulation, and provide strategic recommendations that de-risk investment decisions and support smarter portfolio growth.

How do Strategic Early Development and the Bio Venture Catalyst Solution work together to support biotech investments?

These two solutions are designed to work in tandem. Strategic Early Development ensures robust, data-driven planning from preclinical through clinical stages, while the Bio Venture Catalyst Solution integrates this expertise into a tailored offering. Together, they provide a cohesive path for identifying promising assets, accelerating development, and supporting portfolio companies through key milestones, maximizing both speed and scientific rigor.

Can Certara help support our portfolio of companies after the initial investment?

Yes. We serve as an extension of your portfolio companies by filling gaps in scientific, regulatory, and clinical expertise. From IND enabling, preparation and regulatory submissions to clinical trial design and execution, including pediatric plans, we provide customized support to help your investments reach key inflection points faster and more efficiently, empowered by model-informed drug development (MIDD) and strategic planning.