CDMO Support

Contract Development and Manufacturing Organizations (CDMO) and the Client– How Tunnell supports both parties. CONTRACT SERVICES ARE PART OF NEARLY ALL DRUG DEVELOPMENT STRATEGIES

Contract Development and Manufacturing Organizations (CDMO) and the Client– How Tunnell supports both parties.

CONTRACT SERVICES ARE PART OF NEARLY ALL DRUG DEVELOPMENT STRATEGIES

The use of contract services in the biopharmaceutical drug development and approval process expands capabilities, allowing companies to focus resources on what matters most in the critical drug development efforts. The use of external providers requires a strong relationship. Both parties require a careful strategy throughout the entire process, and both partners should ensure they are a good fit for each other…not just during partner selection, but also during the delivery phase, ensuring a commitment to quality and regulatory management, and the ongoing maintenance of the contract relationship.

SUPPORTING THE ENTIRE PRODUCT LIFECYCLE

Tunnell Consulting delivers end-to-end CDMO consulting and support services throughout the entire contract service lifecycle. Tunnell’s expertise spans areas including regulatory (gap analysis, training staff for inspections, and performing client audits); manufacturing (supply chain strategy); quality and compliance (build a quality management system, develop the team’s inspection readiness skills, and perform quality audits); equipment and capabilities lifecycle and risk management; business development, contract management, operational improvements, and tracking all costs to build into client pricing.

SOLUTIONS TO THE INEVITABLE CHALLENGE

The potential for significant delays or process changes is nearly guaranteed. Supporting improvements in output and productivity, reducing risk, building quality metrics, and mapping a speed to market are opportunities that support both parties. Use of contract services can deliver sustained value creation throughout the entire product lifecycle, but without strong oversight and expertise behind the contract process, the potential may not be fully realized. Technology transfer may be more complex than expected, and choosing the wrong CDMO partner may result in delays or communication gaps.

Being proactive about these challenges is where Tunnell Consulting shines. We make sure that you get the greatest value from your CDMO relationships – and that those relationships continue to deliver long–term value.

TUNNELL INSIGHTS: CONTRACT SERVICE PROVIDERS ARE PART OF YOUR PROCESS!

In our insightful four-part series, Tunnell provides a detailed roadmap on how to prepare for, collaborate, educate, monitor, and reward or terminate these critical relationships and gain the greatest amount of value throughout every step of the process.

This report begins with Part 1, which analyzes the negotiation of contracts and partner selection. Part 2 analyzes the delivery phase, building productive collaboration, and how to overcome unexpected challenges; and Part 3 addresses quality and regulatory management issues. Finally, Part 4 looks at the post-contract phase after the work has begun, contract compliance, and keeping the relationship productive over time.