CMC and Manufacturing Consulting
Maximize your development efficiencies, identify and reduce potential risks, and implement your process development and manufacturing solutions to enable clinical studies no matter what phase your program is in.
Discover the Right Balance Between Cost, Safety, and Patient Access
Developing a new drug in a compliant way through every phase of the regulatory process is a noble and daunting endeavor.
It carries a considerable amount of risk including delayed timelines, loss of millions of dollars, or, worst of all, a potentially life-saving treatment for many people may not be realized.
It is essential that your work is not hindered by inefficient cost allocations, delayed timelines, or insufficient clinical trial material.
Accelerate Your Path to Approval
Identify & Mitigate CMC Risks
When developing a product, it is critical to manage both product and patient risks.
Unfortunately, during drug development, many companies overlook CMC risks resulting in delayed timelines, increased costs and rework.
Phase appropriate development and manufacturing is critical to your success.
TKD Solutions Services
Accelerate Your Path to Approval
Process Development
Process Development
Manufacturing
Manufacturing
Process
Validation
Process
Validation
Analytical
Services
Analytical
Services
Project Management
Project Management
Quality
Assurance
Quality
Assurance
CMC Regulatory Affairs
CMC Regulatory Affairs
Supply Chain Management
Supply Chain Management
Cross-Departmental Support
Cross-Departmental Support
An End-to-End Extension
of Your Team
TKD Solutions provides much more than consulting. We can become a full extension of your team in every phase. Our team runs deep and has subject matter experts ready to help wherever you are in your path to approval journey. TKD team members are chosen for their technical expertise and ability to work well with others. We can even act as your representative to your vendors, CROs, and CDMOs.
Strategy + Execution
We don’t just tell you what needs to be done. We roll our sleeves up and show you how to do it.
Identify and help mitigate risks from pre-clinical through commercial.
Connect you with and manage the CDMOs, vendors, and CMC experts needed to carry out your CMC activities.
Identify and develop your CMC strategy through innovative solutions and state of the art technologies.
Author and provide all technical and regulatory documentation.
We Save Our Clients Millions
Because we bring decades of experience to this space, we know how much things actually cost, and know what needs to be done for each phase of development.
Organizations that aren’t sure what to look for often end up wasting millions on unnecessary costs. We’ve built our reputation on the combination of our expertise and ability to provide an unmatched return on investment for our clients.
Getting Started with TKD Solutions is Easy
Contact Us
Call, email, or send us a message with your information through the contact form on this website.
Discovery Consultation
We’ll schedule a time to discuss what you need and what your timeline looks like. If we’re a good fit we’ll get started on a contract, CDA, and SOW.
Join Your Team
After all the t’s are crossed, and i’s are dotted, we get to work on solving your problem and accelerating your path to approval.
Your Hands On CMC Consulting Partner
TKD Solutions, LLC provides CMC and manufacturing consulting services with strategic and hands-on experience to aid clients in bringing products to market efficiently and with quality in mind.
Ready to Find the solution to get your product to the people who need it most?
Focus on what you do best and we’ll do the rest.