Pharma & Biotech Due Diligence Services

Manufacturing facility assessments evaluate the physical and operational condition of pharmaceutical manufacturing sites for buyers, investors, and lenders. Our senior advisors walk through facilities, review utility systems, assess cleanroom classifications, evaluate equipment for intended use, and benchmark capacity against the deal thesis.

The assessment surfaces capex requirements to bring the facility to operational standard, identifies bottlenecks and constraints, flags regulatory and GMP exposures visible during inspection, and quantifies the time and cost required for the buyer to reach its intended productivity. These assessments frequently serve as GMP facility diligence in advance of a closing decision.

Process robustness diligence assesses whether the target’s manufacturing processes are stable, validated, and scalable for the buyer’s intended use. The work covers process validation status, batch consistency data, deviation history, control strategies, and analytical method robustness across the production sequence.

Our diligence process is led by advisors with hands-on experience operating the relevant manufacturing modalities. The output is a defensible assessment of whether processes will hold under increased volume, technology transfer, or regulatory scrutiny, and a prioritized list of process risks the buyer should price into the deal or address post-close.

Technical transfer risk is one of the most consequential and most underestimated factors in pharmaceutical acquisitions. When a buyer plans to relocate production, change CDMOs, or scale manufacturing post-close, the cost and timeline of that transfer can swing deal economics by hundreds of millions of dollars and add years to the post-close timeline.

We evaluate the realistic technical transfer profile for the asset, including process complexity, equipment dependencies, affected analytical methods, regulatory filings, and the operator capability required to execute the transfer. The output is a risk-weighted transfer plan with cost ranges and timeline estimates that the buyer can use for valuation modeling and deal structuring.

Regulatory diligence reviews the target’s complete FDA, EMA, and applicable global regulatory history, including inspection outcomes, warning letters, recalls, consent decrees, and remediation status. We pair this with a current-state GMP compliance assessment to identify gaps between the asset’s regulatory posture and the buyer’s compliance standards.

The review identifies regulatory risks that affect deal value, post-close integration costs, and the ongoing compliance burden. It also flags items where representations and warranties should be tightened or where escrow holdbacks may be warranted. The output supports both pre-LOI risk pricing and post-LOI confirmatory work within a pharma acquisition due diligence scope.

Pharmaceutical supply chain diligence identifies single-source dependencies, geopolitical exposure, regulatory concentration risk, and operational vulnerabilities that drive post-close supply disruptions. PharmaBioSource reviews the upstream supplier base, raw-material sourcing, intermediate manufacturing dependencies, and downstream distribution logistics for multinational assets.

The review covers concentration risk by supplier and by geography, qualified alternatives available in the market, regulatory exposure tied to specific suppliers, and the contractual structures (long-term agreements, exclusivity, change of control) that affect post-close continuity. We are frequently engaged for assets with substantial multinational supply chain logistics or CDMO dependencies.

When a target relies on contract manufacturers (CDMOs and CMOs) for any part of production, the buyer or investor assumes those relationships, contracts, and operational dependencies. We evaluate each material CDMO relationship: capability fit, performance history, regulatory standing, contractual terms, change-of-control provisions, and qualified alternates in case the relationship needs to be replaced.

The assessment covers both the buyer’s exposure to CDMO performance issues and the contractual flexibility to restructure relationships after closing. This service is frequently bundled with supply chain review and supports CDMO due diligence scopes for both investment and acquisition contexts.

Cost of goods diligence validates the target’s COGS reporting against the underlying manufacturing cost structure. PharmaBioSource rebuilds COGS from the bottom up using operational data: raw material costs, conversion costs by step, yield and waste assumptions, allocated overhead, and CDMO pricing where applicable. We then reconcile the build to the target’s reported financials.

The analysis identifies COGS misstatements (intentional or otherwise), highlights opportunities for post-close cost improvement, and benchmarks the target’s cost position against industry standards. It is frequently used to validate the buyer’s investment thesis or to support negotiation of purchase price adjustments tied to working capital and inventory.

Cash flow diligence in pharma extends beyond historical financials to forward-looking risks that compress revenue or margin: patent expirations, biosimilar entry, generic launch timing, formulary exclusion risk, reimbursement pressure, and competitive launches in the same therapy area. We combine public filings, pharma competitive intelligence, and operator insights to map these threats over the buyer’s holding period.

The output is a forward-looking cash flow risk map that identifies the largest threats and the timeline for their materialization, along with the operational and commercial responses available to the buyer. This service is frequently engaged for pharma investment due diligence scopes where the exit thesis depends on multi-year cash flow durability.

PharmaBioSource’s benchmarking diligence places the target against comparable assets on the dimensions that drive deal valuation: capacity utilization, manufacturing productivity, COGS structure, regulatory posture, and transaction multiples. The benchmarks draw on our proprietary transaction history and operator data, calibrated to the asset’s modality, scale, and geography.

The output is a defensible peer set with quantified comparison on the metrics most relevant to the buyer’s thesis. It is used to validate management’s representations, identify outlier risks or opportunities, and support negotiation of valuation. Engagements range from one-off benchmarks supporting a specific decision to full biopharma due diligence scopes.

Mock diligence preparation is the seller-side counterpart to buyer diligence: we conduct the diligence process on the asset before it goes to market, surfacing the issues a sophisticated buyer would identify and giving the seller time to remediate, restructure, or position around them. It is frequently engaged ahead of pharma sell-side advisory mandates.

The work covers the same scope that a buyer would conduct: technical, regulatory, operational, supply chain, and financial diligence on the asset. The output includes a remediation roadmap, a tightened data room, and a defensible answer set to the questions buyers will ask. It is most effective when engaged six to twelve months before go-to-market.