CDMO Basics
What is a CDMO?
A CDMO is a company that helps drug makers develop and produce medicines. They support everything from early testing to full-scale manufacturing for their clients.
(Contract Development and Manufacturing Organization)
How does Kneat help CDMOs share large volumes of documentation with their clients faster and more securely?
With paperless handover, which allows quick and secure digital document sharing with external stakeholders.
Name one major CDMO that is a Kneat customer.
Thermo Fisher Scientific, Fujifilm, Merck, ElevateBio, Novartis, Eurofins Scientific, Baxter International, AbbVie, Gerresheimer
True or False: CDMOs always use the same validation process across customers.
False.
CDMOs work with multiple clients, each with their own templates, standards, and documentation needs.
That means validation isn't the same of every clients.
What key activity must CDMOs always be ready for, internally and externally?
Audits
Which department is usually responsible for ensuring validation compliance in CDMOs?
Quality Assurance
Name 2 services a CDMO might offer.
Drug development, clinical trials, commercial manufacturing
Why is documentation management more difficult for CDMOs than for regular manufacturers?
Because they need to share large volumes of documents with their customers.
If you're speaking to someone in IT or Digital Transformation, what might their priority be?
They're focused on modernizing systems and making validation more efficient through digital tools.
What happens if a CDMO doesn't solve these validation challenges?
They risk delays, higher costs, and losing customers.
How does Kneat help CDMOs save time and money?
By cutting down validation time and avoiding errors or delays.
Name 3 job titles that could be key decision-makers or champions for Kneat in a CDMO
VP of Validation
Head of Quality Systems
Director of C&Q (Commissioning & Qualification)
How do CDMOs benefit financially from using a digital validation solution like Kneat?
They save time and resources, reduce non-compliance risks, and accelerate project delivery, which improves margins and client satisfaction.
In the CDMO world, time = money. Every delays affects their ability to take on new clients or deliver current projects.
Kneat helps reduce execution and review time, eliminates manual errors, and improves operational efficiency.
If a CDMO mention they're "not looking right now," what follow-up value can you offer?
Share how other CDMO use Kneat to save time and stay compliant, especially during audits or new client onboarding.
When a CDMO says "we're not looking right now," it doesn't mean there's no opportunity, it often means "we don't feel urgent pain" or "this isn't top of mind today".
What you can say:
"I understand that you're not actively looking. Just thought this might be useful: we're seeing a lot of CDMOs' like Thermo Fisher and Fujifilm using Kneat to speed up client onboarding, keep audit readiness under control, and reduce validation review time by 50-58%.
I'd be happy to share a quick example or leave something with you for when the timing is right."
(Technical)
Which validation processes important to CDMOs are improved by using Kneat?
Process transfer, method transfer, batch records, product changeover, and cleaning validation.
Why it matters to CDMOs: because these processes are repeated often as CDMOs work with multiple clients and products. Each client may have different standards, and every transfer or product change require fast, accurate validation.
With Kneat, CDMOs can confidently manage complex, high-volume validation workflows while staying fast, compliant and competitive.
Why is speed critical in the CDMO business model?
Because customers expect rapid scale-up and delivery of products.
CDMOs are hired to be fast, flexible, and efficient. Delays hurt their clients, which means validation must happen quickly and without error.
Example of a hook in outreach:
"Many CDMOs struggle to meet client timelines due to slow, manual validation processes, is that something you're also dealing with?"