Early Development & Pre-Clinical Services

From research and discovery to early development and pre-clinical

 

Streamlining development of your lead assets so you can confidently submit your investigational new drug (IND) application

 

With our combined CDMO and CRO—“CRDMO”—expertise, Thermo Fisher Scientific supports your early drug development and pre-clinical requirements. We help develop your lead assets and confidently submit your investigational new drug (IND) application by fully supporting your drug development strategy, sourcing, regulatory, and laboratory testing requirements, while also planning ahead to obtain data needed for streamlining future clinical phases for your asset.

Case study:

  • A biotech company saved over $1M in API costs and accelerated the time to their first-in-human study by 12 months because our experts identified and resolved CMC and regulatory issues.
  • This was achieved by utilizing the depth of drug development technical expertise and regulatory knowledge within Thermo Fisher Scientific, and having direct access to high-quality manufacturing and lab services.

Our unique, fully end-to-end approach ensures shared accountability across the early development and pre-clinical process, and helps to enable increased speed, simplicity, and scalability.


Early development and pre-clinical services across your drug development journey

Select any of the early development and pre-clinical topics to learn more details about how we can help you develop your assets, complete your IND application, and plan for success in future clinical phases.


 

 

 

Building an ecosystem of connected CRDMO services to support your asset development

We’ve forged a unique approach backed by decades of experience and know how.

 

Central to this approach is accountability, ensuring that across drug substance manufacturing, drug product manufacturing, clinical supply, and clinical trial research there is a collaborative approach, with joint program management and data transparency—leading the way to exceptional outcomes.


Speed

Accelerate your asset development and proactively mitigate risks

Simplicity

Fewer vendors, centralized governance and program coordination for streamlined execution

Scalability

Global networks with regional expertise for seamless scale-up