Due Diligence & In Licensing

Due Diligence and In Licensing for Confident Pharma Investments

Due diligence and in licensing succeed or fail on CMC and manufacturing reality, not just the story in the deck. Pharmatech brings over 30 years of CMC, Quality, and regulatory experience, paired with advanced in silico and diagnostic capabilities, to deliver an early, calibrated view of technical and compliance risk before major capital is committed. We identify the issues that most often drive delays, rework, and inspection risk, then translate them into clear deal implications and a prioritized mitigation roadmap. The result is improved capital efficiency and faster time to market, plus stronger exit positioning and valuation uplift driven by a cleaner risk profile, well documented readiness, and a credible, regulator aligned CMC story that stands up in buyer diligence.

Examples include:

CMC and Manufacturing Readiness Scorecard: decision grade view of what is real versus assumed
Quality Systems and Inspection Readiness Diagnostic: early red flag assessment of QMS maturity and compliance risks that can derail phase appropriate development
Tech Transfer and Comparability Risk Review: clarifies comparability approach, data gaps, and execution risks that impact timelines and approval probability
Stability and Control Strategy Assessment: stress tests shelf life strategy, specifications, analytical readiness, and control strategy robustness mapped to global regulatory expectations
Modeling Led Capital Efficiency Plan: in silico informed pathway to focus experiments, reduce rework, and accelerate time to market, improving capital efficiency and strengthening IRR and MOIC

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Due Diligence and In Licensing for Confident Pharma Investments

Uncover CMC and Regulatory Risks Before You Commit

Our consultants bring decades of technical, regulatory, and quality expertise to ensure opportunities are evaluated accurately. We dig into the details that determine long term success, from regulatory filings to facility compliance.

Key areas we assess:

Development stage CMC data and regulatory readiness
DS and DP manufacturing capabilities, scalability, and compliance
Analytical methods, validation, and comparability planning
Facility and supplier oversight structures
Alignment with FDA, EMA, and global health authority expectations

Strategic Insights for Acquisitions and Partnerships

Pharmatech supports both acquirers and licensors in making informed, confident decisions. We validate data packages, identify gaps, and provide clear recommendations that impact valuation, deal structure, and long term performance.

Our support includes:

Harmonization of QMS and compliance frameworks
Facility readiness assessments and CQV planning
Integration strategies post close or post licensing
Remediation of legacy gaps and FDA findings
Development of CMC roadmaps aligned with regulatory filings

Strategic Insights for Acquisitions and Partnerships

Protect and Enhance Deal Value

Our due diligence and in licensing services provide a clear, data driven picture of technical, regulatory, and quality risks. We deliver insights that safeguard investments and position programs for success.

We help you:

Avoid hidden liabilities that erode deal value
Identify opportunities for process optimization and cost savings
Build regulatory confidence with phase appropriate strategies
Enable faster path to market and revenue realization

Make Smarter Investment and Licensing Decisions

Whether you are evaluating a single asset, acquiring a platform company, or negotiating an in licensing deal, Pharmatech Associates provides the technical and regulatory expertise to reduce risk and maximize opportunity.

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Let’s Get Started

Our unique approach can help your company navigate the complexities of launching a drug, biologic or medical device into multiple markets. The first step? Connecting. Simply fill out our form and a representative will follow-up shortly.

1.877.787.0177

510.732.0177

Pharmatech Associates, Inc. 9110 Alcosta Blvd. STE H #601 San Ramon CA 94583