Here is a compilation of some FAQs that might help you. If you can’t find what you’re looking for here please don’t hesitate to reach out and ask.

1. Does TKD Solutions offer vendor oversight?


We can work directly with your CMC vendors to ensure your projects and programs stay on budget and on schedule.

2. Do you work with startups?

Yes! We work with small startups all the way through large pharma organizations.

3. Is my company too large (or too small) to benefit from working with TKD Solutions?

We can help with both large and small CMC projects at any stage of development, and on single issues.

4. My company is developing more than one asset.
Can TKD Solutions support multiple projects at varying stages?

Yes we can!

5. Is support from TKD Solutions limited to the United States?

We support clients and CMC work occurring all over the world.

6. Can TKD Solutions support authorship of regulatory filings?


7. Can TKD Solutions provide training on topics related to pharmaceutical manufacturing or testing?

Yes – we can provide training anywhere from a high level overview all the way to training a team to execute and support CMC work on a detailed basis.

8. Can TKD help me with just one part of a project?


9. Will I have dedicated support from specific TKD team members for my project?

Yes, you will have a primary point of contact within TKD, but will benefit from having access to any/all members (and their expertise) of TKD throughout the course of your project.

10. What makes TKD different from other consulting firms?

We offer a team of highly experienced CMC experts for your project, at a competitive rate. We pride ourselves in our ability to integrate into teams and get the job done in a compliant manner while implementing appropriate regulatory strategy.

11. What are the first steps I need to take in order to understand if TKD is the right fit for my company’s CMC needs?

Reach out to us today and tell us about your projects and requirements.

12. Do you have experience with products in all phases of development (pre-IND to commercialization)?


13. Can TKD support clinical programs in Europe and other regions outside the United States?


14. Does TKD have a laboratory or can it function as a CRO?

No but we are happy to help you identify the right laboratory and/or CRO for your needs!

Focus on what you do best and we’ll do the rest.