Navigating towards success
​"The most important decision in a business partnership is not what you're going to do but who you're going to do it with." — Warren Buffett
CDMO Selection
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Having both hired CDMOs and worked for several of them, my unique dual perspective has taught me how to identify the perfect partnership for your needs.
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​Sample questions we will explore:
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What are the regulatory requirements?
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Design firm vs. CDMO vs. CMO?
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What is a must, and what is negotiable?
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What are the factors with the CDMO that will affect speed and cost?
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What are the factors in the supply chain that will reduce delay during a pivot?
"The friction between partners with different perspectives isn't a bug in the system—it's the feature that drives innovation. Embrace the discomfort."
— Arianna Huffington
CDMO Management
Just like in marriages, strain in professional relationships rarely stems from one side alone. I've successfully turned around 3 challenging client relationships in the past 3 years. Would love to help with yours!
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Key Factors:
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Regulatory strategy alignment.
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Contract proposal draft and review.
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Establish reporting and communication protocol.
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Execute performance, schedule, and budget reviews.
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Risk management.
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Executive summary reports.
Experience Seamless Medical Device Development and Manufacturing
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Expert guidance tailored to your unique needs.
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Proven strategies from managing over 50 contracts in the last 3 years.
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Experience working as PM consultants in multiple CDMOs.
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Successfully turned 4 sets of chaotic engagements to order.
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Hands-on experiences in every development and manufacturing phase.
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Rutinely identified risks and proactively mitigated them to save costs and months of time.
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Experience working with regulatory team members to strategize in different project stages to map out optimum paths and understand regulatory and quality constraints.
Consulting Solutions:
Three Flexible Approaches
1
CDMO Evaluation
For a flat fee:
360 Evaluation on CDMO of your choice using our comprehensive checklist. Provide an evaluation report with pros/cons. Identify risks and mitigation recommendations.
2
CDMO Selection
For a flat fee:
Expert guidance tailored to your unique needs. Support an 8-week comprehensive search and due diligence.
Offer recommendations for CDMO candidates,
Provide eval and comparison reports for up to 3 CDMOs.
3
CDMO Management
For a x% of the contract:
First month Satisfaction Guaranteed.
I manage your CDMO on a day-to-day basis so you can focus on growing the business and setting up the strategy.
Including the key factors in CDMO management section above.