Frequently Asked Questions
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.
Q: Does TKD Solutions offer vendor oversight?
A: Absolutely. We can work directly with your CMC vendors to ensure your projects and programs stay on budget and on schedule.
Q: Do you work with startups?
A: Yes! We work with small startups all the way through large pharma organizations.
Q: Is my company too large (or too small) to benefit from working with TKD Solutions?
A: We can help with both large and small CMC projects at any stage of development, and on single issues.
Q: My company is developing more than one asset. Can TKD Solutions support multiple projects at varying stages?
A: Yes we can!
Q: Is support from TKD Solutions limited to the United States?
A: We support clients and CMC work occurring all over the world.
Q: Can TKD Solutions support authorship of regulatory filings?
Q: Can TKD Solutions provide training on topics related to pharmaceutical manufacturing or testing?
A: 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.
Q: Can TKD help me with just one part of a project?
Q: Will I have dedicated support from specific TKD team members for my project?
A: 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.
Q: What makes TKD different from other consulting firms?
A: 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.
Q: 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?
A: Reach out to us today and tell us about your projects and requirements.
Q: Do you have experience with products in all phases of development (pre-IND to commercialization)?
Q: Can TKD support clinical programs in Europe and other regions outside the United States?
Q: Does TKD have a laboratory or can it function as a CRO?
A: No but we are happy to help you identify the right laboratory and/or CRO for your needs!
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