Alacrita's due diligence team has been a trusted DD source for over 17 years, conducting assignments for large pharma, biotech, universities, and investors. Every assessment is tailored to the specific opportunity, incorporating consultants with direct experience in the relevant therapeutic area and modality for a thorough and accurate evaluation.
Trusted by pharma, biotech, and investors to get it right.
Types of Due Diligence
DD scope depends on the transaction, development stage, and specific risk areas requiring assessment.
Pre-DD / Triage
Rapid assessment using publicly available information to identify red flags before committing to full DD.
- Competitive landscape assessment
- High-level risk identification
- Go/no-go recommendation
Technical and Market
Comprehensive data room review and assessment across clinical, regulatory, CMC, IP, and commercial domains.
- Domain-specific expert teams
- Risk quantification and mitigation
- Management call participation
DD Readiness
Preparing for incoming due diligence from partners, acquirers, or investors. We review your program the way an incoming DD team would: pressure-testing claims, checking source data against presentations, and identifying questions you'll face. Also relevant for pharma preparing assets for divestiture or out-licensing.
- Identify gaps before they're discovered
- Align presentations with source data
- Develop proactive disclosure strategy
- Strengthen negotiating position
DD Assessment Domains
Comprehensive technical DD covers multiple functional areas, with depth calibrated to the asset's stage and the transaction's risk profile, including:
Clinical & Scientific
- Mechanism of action validation
- Preclinical data package review
- Clinical study report analysis
- Efficacy and safety assessment
- Probability of technical success
Regulatory Strategy
- Agency correspondence review (FDA, EMA, Health Canada, and other major authorities)
- Pathway viability assessment
- Expedited program eligibility
- Label and indication scope
- Multi-regional strategy alignment
CMC & Manufacturing
- Process development status
- Scale-up readiness
- Analytical method validation
- Supply chain assessment
- CDMO capability evaluation
Intellectual Property
- Review existing IP opinions and patent filings
- Identify gaps requiring attorney analysis
- Assess commercial implications of exclusivity timeline
- Flag license agreement issues and third-party dependencies
- Coordinate with client's IP counsel or recommend qualified firms
Commercial Viability
- Competitive positioning/differentiation assessment
- Pricing and reimbursement outlook
- Market access barriers/payer perspective
- KOL and payer perspective
- Go-to-market strategy and resources
Operational & Financial
- Development budget assessment
- Timeline realism
- Team capability evaluation
- Vendor contract review
- Burn rate analysis
Our DD Process
From Scoping to Risk Assessment
Every DD engagement is tailored to the specific transaction, but follows a disciplined process. We focus attention where risk is highest and deliver findings in formats that support decision-making.
Scoping & Team Assembly
Define scope based on transaction type and specific concerns. Match the right expertise to the assessment.
Data Room Review
Systematic review of mechanism of action data, preclinical and clinical data, regulatory correspondence, CMC documentation, IP filings, and commercial materials, etc.
Assessment
Consultants evaluate findings, identify issues requiring clarification, and assess risk impact and identify any potential remediations.
Risk Report
Deliver findings highlighting deal killers, serious concerns, and normal findings. Provide mitigation recommendations.
How We Engage
Most clients engage us to run end-to-end DD; others bring us in for specific domains or independent validation. We adapt to your process, timeline, and governance requirements. For competitive situations, we can mobilize quickly. For extended decision processes, we remain available as findings get socialized internally and new questions emerge.
Who We Serve
Different clients bring different questions to DD. We calibrate our assessment to what matters most for your decision.
Pharmaceutical Companies
Evaluating in-licensing opportunities, acquisition targets, or partnership candidates. Supplementing internal DD teams or running independent assessments.
Biotech Companies
Preparing for incoming DD from partners, acquirers, or investors. Identifying issues before they surface in negotiation. Also conducting outbound assessment when evaluating collaboration opportunities or potential acquisitions of your own.
Venture Capital
Early-stage investment DD focused on scientific thesis validation, team assessment, and development pathway.
Private Equity & Institutional Investors
Later-stage DD emphasizing commercial viability, operational risk, and value creation pathway. Accessible explanations for non-specialist investors.
Universities, Tech Transfer Offices & Accelerators
Assessing spin-out readiness, evaluating commercialization potential, and preparing academic programs for industry partnership or licensing discussions.
Representative Engagements
Selected case studies from DD assignments spanning therapeutic areas, modalities, and transaction types.
Pre-DD & Triage
Pre-DD Assessment of First-in-Class Allergy Therapeutic
+Situation
A pharmaceutical company evaluating a European biotech with a first-in-class compound for allergic conditions. Strong preclinical package, but early clinical efficacy readouts were modest.
Our Work
A former CMO with allergy experience assessed the preclinical and clinical data. The preclinical studies (mechanistic work, disease models, safety pharmacology) exceeded typical standards for this stage. Analysis of the early clinical results suggested the modest efficacy reflected conservative study design choices rather than mechanism limitations.
Outcome
Concluded that the scientific foundation offset early clinical concerns. A well-designed Phase 2b could provide definitive proof-of-concept. Client proceeded to full DD with clear understanding of development risks and pathway.
Read full case study →Pre-DD Evaluation: Advising Against Full Due Diligence
+Situation
A mid-cap pharmaceutical company exploring licensing and co-development opportunities in women's health identified a promising early-stage startup. With limited internal resources for early screening, they engaged Alacrita to conduct a pre-DD assessment to determine whether the opportunity merited full due diligence.
Our Work
We deployed a cross-functional team led by a former CMO with deep women's health experience. The team conducted thorough analysis of the startup's preclinical data package, including NHP studies and proof-of-concept findings. We assessed scientific rationale, development risk, estimated timelines, and resources required to progress to clinical stages.
Outcome
Our review concluded that while the therapeutic concept had potential, the preclinical data did not support readiness for IND-enabling studies. Significant additional work would be required, implying long timelines and substantial resource commitments. We advised against initiating full due diligence, allowing the client to preserve bandwidth for more advanced opportunities.
Read full case study →Technical Due Diligence
High-Risk Pediatric Oncology Biologic
+Situation
A PE-backed specialty pharma company considering acquisition of a mAb targeting rare pediatric oncology. The asset had been developed through a US university hospital and was available following a disappointing FDA end-of-Phase 2 meeting.
Our Work
Our DD team brought in three specialists: a regulatory CMC specialist with biologics expertise, a senior regulatory affairs consultant with former agency experience, and a pharmaceutical oncologist with pediatric experience. The assessment focused on implications of FDA feedback, identifying uncertainty across regulatory, clinical, and technical domains.
Outcome
Characterized as high-risk, but the client's internal team had relevant therapeutic area experience. Armed with our findings and mitigation strategies, they proceeded with acquisition. We continued supporting clinical development post-transaction.
Read full case study →Late-Stage Gene Therapy DD for Global Pharma
+Situation
A global pharmaceutical company faced a short deadline to make an offer for a late-stage gene therapy asset under considerable competitive deal pressure. This would be their first gene therapy acquisition, and they lacked internally the specialized personnel for expert DD.
Our Work
Within a two-week period, we brought in the specialists required: a highly experienced physician, an ex-FDA gene therapy regulatory specialist, a gene therapy CMC specialist, and a quality specialist. The team assessed the data room and identified critical issues, including areas where the target had not yet disclosed relevant documentation.
Outcome
Our specialist work complemented what the client's internal (non-gene-therapy-experienced) team had done. The combined assessment informed the deal team's decision on how to proceed.
Read full case study →Early-Stage Live Biotherapeutic Assessment for VC Reinvestment
+Situation
An early-stage venture fund asked us to review the opportunity for reinvestment in a biotech developing a novel live biotherapeutic for inflammatory bowel disorders. They needed to evaluate both the data generated and the company's work plan for future preclinical data collection.
Our Work
We conducted a three-stage program: (1) literature review of live biotherapeutic developments and therapeutic differentiation in IBD, (2) KOL interviews using pre-read documents summarizing the company's work plan and data, and (3) synthesis into a report with prioritized conclusions.
Outcome
Delivered a report outlining key conclusions with high and low priority items for the scientific team to address in order to maximize project value ahead of more substantial fundraising.
Read full case study →DD Readiness
Preclinical ADC Company Prepares for Investors
+Situation
A preclinical biotech developing ADCs targeting GPCRs for solid tumors asked us to conduct an internal DD and reality check before approaching investors. Their most advanced asset was an ADC with preclinical data in melanoma treatment.
Our Work
We reviewed pharmacology reports, toxicology and preclinical study reports, indication selection rationale, clinical development plans, budgets and timelines, and IP position. We identified risks across melanoma and other possible indications, quantified impact, and suggested mitigation strategies. We also assessed the competitive landscape for both the indication and mechanism.
Outcome
Based on our assessment, the company pivoted to a new ADC toxin and linker combination and reoriented the program toward a different, more defensible indication. These changes strengthened their position before investor discussions.
Read full case study →Regulatory Dossier Review Before Out-Licensing
+Situation
A biotech with a novel oral drug delivery technology platform was looking to out-license its lead asset, a reformulated generic therapeutic in a new, non-opioid pain indication that had recently completed Phase 2 trials.
Our Work
We conducted a detailed review of data room contents and additional materials, holding discussions with the company to seek clarification around key issues. We compiled findings into a report describing the nature and level of each issue identified.
Outcome
Although the dossier was in good shape overall, we identified minor errors, omissions, and inconsistencies. These issues would have surfaced during partner DD. The company corrected them before any partner saw the materials.
Read full case study →Annual DD Program for Life Science Incubator
+Situation
A non-profit research incubator, accelerator, and seed funder runs competitive programs selecting early-stage drug development projects for funding. After shortlisting applications, they needed external technical and commercial assessment before confirming selections.
Our Work
Alacrita conducts 8-10 due diligence reviews annually using a standardized format adapted to each technology and development stage. Our team assesses scientific rationale, preclinical proof-of-concept data, CMC plans, clinical development strategy, competitive positioning, and market potential. We highlight key risks, propose mitigation strategies, and recommend near-term experiments to de-risk projects and generate credible data. Deliverables include detailed slide decks for each project and review calls with the client team.
Outcome
The retained relationship provides consistent, calibrated assessments that support the client's funding decisions across their portfolio programs year after year.
Where Problems Hide
These issues surface repeatedly across DD engagements. Knowing where to look is half the battle.
Presentation vs. Source Data Mismatch
Management decks claim "strong efficacy signal" but clinical study reports show p=0.048 with missed secondary endpoints. Investor presentations don't match FDA correspondence. Never believe the PowerPoint without checking source documents.
IP Chain-of-Title Issues
Licensed technology where the licensor lacked authority to grant the license. University inventions where institutional consent was never obtained. Royalty stacking that severely compromises asset economics. These issues compound over time.
CMC and Supply Chain Blind Spots
Companies assume commercial supply chain work can wait until Phase 3. Launch timelines assume clinical supply can serve initial market demand. Sole-source API suppliers without backup. Tech transfer to CDMO not initiated.
Commercial Viability Gaps
Assets with clear regulatory pathways but no market. Payers won't reimburse, KOLs won't prescribe. Technical DD passes but commercial DD fails. Insufficient differentiation from existing options despite unmet medical need.
Regulatory Pathway Assumptions
Development plans assuming expedited pathways that FDA hasn't confirmed. Open agency questions presented as resolved. Clinical hold history undisclosed. Conditional approval dependencies buried in correspondence.
Team and Operational Risk
Key person dependencies not disclosed. Burn rate projections assume favorable scenarios. Clinical trial accruals under-reported until vendor contract reconciliation. Soft assets (the people who make programs succeed) often neglected in DD.
DD Best Practices & Pitfalls Whitepaper
Deeper exploration of common DD issues and how to avoid them, for both acquirers and target companies.
Why Alacrita for Due Diligence
Matched Expertise
We incorporate consultants with direct experience in the relevant therapeutic area and modality. The right expertise for each opportunity ensures assessments are precisely on target.
Industry Operators
Our consultants are former CMOs, VP Clinicals, heads of regulatory and CMC, and commercial leaders. They know where problems hide because they've encountered them in their own programs and prior DD exercises.
Depth of Experience
17 years of DD work across therapeutic areas, modalities, and transaction types. That experience informs what questions to ask, where to focus attention, and how to distinguish real risks from routine findings.
Accountable Throughout
Alacrita manages every engagement from scoping through final deliverable. We review all work product, coordinate across domains, and remain your point of contact throughout.
From Assessment to Negotiation
DD findings are only useful if they're actionable. We frame technical risks in terms that support deal negotiation, identifying which issues warrant price adjustments, escrow holdbacks, or specific contractual protections. Your legal and BD teams handle final structuring; we provide the technical foundation.
Common Questions
Scope & Process
What does technical/market due diligence cover?
+Clinical data and development strategy, regulatory pathway and agency interactions, CMC and manufacturing readiness, IP position and freedom-to-operate, and commercial viability. Scope depends on the asset stage, transaction type, and specific risk areas. Not every DD covers every domain.
How long does a due diligence engagement take?
+Timeline varies based on engagement type, asset stage, data volume, scientific complexity, and scope of domains being assessed. Pre-DD triage is faster than comprehensive technical DD. We can often move as quickly as a transaction requires; expedited timelines are possible when deal timing demands it.
What outputs does Alacrita deliver?
+Written DD report, risk assessment categorizing findings by severity, and mitigation recommendations. We can present findings directly to investment committees or boards. Format is tailored to client needs.
Can Alacrita work alongside our internal DD team?
+Yes. We adapt to your workflows: contributing to specific domains, participating in your meetings, working within your templates, presenting to governance committees. We're accustomed to integrating with varying internal processes.
Working With Us
How is Alacrita different from other DD providers?
+Assessments are tailored to each opportunity, with consultants matched to the relevant therapeutic area and modality. Over 17 years, we've worked with hundreds of clients across the industry - investors, biotech, pharma, and academia - many of whom return to us repeatedly.
Can you help prepare for incoming due diligence?
+Yes. DD readiness work surfaces issues that would otherwise emerge during negotiation: gaps in documentation, inconsistencies between presentations and source data, risks that benefit from proactive disclosure. Better to find issues yourself than have them discovered.
Can Alacrita support post-DD activities?
+DD often identifies issues requiring ongoing attention. When transactions proceed, we can continue supporting clinical development, regulatory submissions, CMC remediation, or other workstreams. Several long-term client relationships began with DD engagements.
Can you help translate DD findings into deal terms?
+We can help bridge technical findings to commercial implications, identifying which risks warrant escrow holdbacks, milestone adjustments, or specific representations and warranties. Final deal structuring involves your legal and BD teams, but we frame findings in terms that support negotiation. For clients who want hands-on support through negotiation and deal structuring, our partnering and deal-making team can continue the engagement.
Expertise & Confidentiality
Do you work with investors who aren't life science specialists?
+Yes. We frequently work with institutional investors, family offices, and funds without in-house biotech expertise or with limited internal resources. We provide accessible explanations of technical risks alongside detailed assessments.
Do you have regulatory expertise beyond FDA and EMA?
+Yes. Our regulatory consultants have experience across FDA, EMA, Health Canada, TGA, and other major authorities. For global programs, we assess strategy across regions and identify where requirements diverge.
How do you handle conflicts of interest and confidentiality?
+We screen for conflicts before every engagement. Consultants who have worked on potentially competing assets are excluded, and we track this at the individual level. All consultants operate under confidentiality agreements, engagement-specific NDAs are standard, and we maintain information barriers between workstreams. For clients with ongoing deal flow, we establish conflict protocols upfront, defining how we handle situations where we've previously worked with a potential target and documenting conflict checks for your records.
Discuss Your Due Diligence Needs
Tell us about your situation and we'll connect you with a relevant consultant to discuss how we can help.