What we offer

• Target screening: early assessment of opportunities against your investment criteria
• Commercial due diligence, including market access due diligence, to assess a target's commercial viability and positioning
• Regulatory due diligence to identify compliance gaps, approval risks, and pathway feasibility
• Manufacturing due diligence to evaluate operational and quality readiness
• Post-merger integration support, ensuring regulatory and quality continuity once a deal closes

These services can be combined or delivered separately, tailored to the specific focus of your deal.

We package expertise by the deal question

• Before You Commit — Deal Screening: Target screening & pipeline mapping, therapeutic landscape & competitor mapping, early regulatory and access risk flags
• Doing the Deal — Deal Conviction: Commercial & market access due diligence, clinical & regulatory pathway feasibility, CMC and GxP readiness review, payer/HTA mock engagement
• Living the Deal — Value Creation: Post-merger integration & operating model, go-to-market strategy & launch sequencing, portfolio optimization, pricing & access execution

The diligence questions we resolve for buyers and sellers

• How real is the unmet need with patients, HCPs and payers? Without unmet need, uptake demands huge investment regardless of clinical merit. We resolve it through patient / HCP / payer primary research and treatment-pathway and guideline review.
• How crowded is the therapeutic landscape, now and at launch? Crowding kills differentiation and premium pricing. We resolve it through analogue and competitor pipeline assessment, SoC selection, and a differentiation map.
• What is the realistic regulatory pathway to MAA? A weak evidence or CMC story leads to delays, CRLs or scope reductions. We resolve it through pathway feasibility review, an early regulator engagement plan, and a CMC readiness check.
• Does the evidence support optimal pricing, reimbursement and uptake? Evidence misaligned with payer needs limits price and shrinks the model. We resolve it through payer/HTA mock engagement, HEOR & RWE strategy, and pricing benchmarks.
• Can the operating model actually execute the launch plan? Execution risk is rarely modelled but consistently destroys post-deal value. We resolve it through target operating model assessment, geographic prioritization, and distribution review.

Due diligence in practice

Real client engagements, anonymized to protect confidentiality.

MedTech — Commercial, Access & Regulatory

The client asked PLG to assess adoption potential and identify regulatory and access risks for a potential acquisition. PLG delivered a competitive analysis, adoption assessment based on clinician interviews, gap identification for CE-Mark approval, and a risk and opportunity analysis.

Rare Disease & Oncology — Access

The client assessed a Phase III compound; work from a generalist consulting firm lacked granularity on access. PLG reviewed the robustness of reimbursement evidence in a changing environment, mapped care pathway, standard of care and competitor pricing in the US, France and Germany, and ran clinician and payer interviews on clinical and price comparators.

Orphan Drug — Regulatory

A biotech looked to acquire an orphan drug and needed a risk assessment for future EU regulatory submission. PLG ran clinical and CMC due diligence from the data room, applied current EU and US regulatory guidelines, and assessed registration risk in an orphan, neonatal indication.