Due Diligence and In Licensing for Confident Pharma Investments

Evaluating or acquiring a pharmaceutical asset demands more than financial analysis. The true value of a program or platform depends on its science, quality systems, manufacturing readiness, and regulatory trajectory. Overlooked CMC or compliance issues can delay timelines, raise costs, or diminish long term value.

Pharmatech Associates, a USP company, delivers comprehensive due diligence and in licensing support across drug substance, drug product, and corporate transactions. We help investors, biopharma companies, and CDMOs validate opportunities, uncover risks, and chart integration pathways with confidence

Due Diligence and In Licensing for Confident Pharma Investments
Uncover CMC and Regulatory Risks Before You Commit

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

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.

Contact Us

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

22320 Foothill Blvd. Suite 330, Hayward CA 94541