Quality & CMC Due Diligence

Translate Quality Risk into Transaction Intelligence

QULLA supports leadership teams, investors and transaction partners with independent quality and CMC assessments that reveal whether an asset or organization can execute its development and manufacturing plans.

What QULLA Delivers

  • Structured review of QMS and regulatory maturity
  • Assessment of manufacturing, analytical and supply-chain risk
  • Identification of hidden remediation cost and timeline exposure
  • Clear, executive-level findings for licensing or investment decisions

Senior-Led, Risk-Based Support

The assessment connects technical evidence with business consequences. It distinguishes manageable gaps from risks that could affect development timelines, regulatory credibility, supply continuity or deal value.

Discuss Your Programme

Questions

Frequently Asked Questions

Which transactions can QULLA support?

Support is available for in-licensing, out-licensing, biotech asset evaluation, CDMO acquisitions, private-equity diligence and strategic partnerships.

Can diligence include on-site assessment?

Yes. Desktop review can be combined with management interviews and on-site quality or manufacturing assessment where appropriate.

Explore all QULLA services · Read the Purple Papers · About Richard van Ewijk

Who We Serve

Built for the Complexity of Modern Drug Development

We work with organizations where the stakes are high and quality excellence is non-negotiable — from advisory to hands-on execution.

Emerging & Clinical-Stage Biotech

Whether entering Phase I or scaling toward later-stage development, we help build quality infrastructure that matches ambition without overbuilding for the current stage.

  • Phase-appropriate QMS design and implementation
  • QP services and IMP quality oversight
  • CMC quality strategy for regulatory submissions
  • Quality DD support for fundraising and licensing

CDMOs & Contract Manufacturers

We help CDMOs sharpen their quality positioning, strengthen governance structures, and demonstrate the operational robustness that clients and regulators demand.

  • QMS optimization and scalability review
  • Audit program design and execution
  • GxP readiness and inspection preparedness
  • Process performance and compliance benchmarking