On your product path from discovery to clinical trials and through commercial drug product manufacturing, we are your resource for regulatory strategy, product and process development, quality assurance, quality control, and quality systems support.
Our expertise reaches from development through commercial manufacturing to meet your end-to-end drug submission needs.
Audrey Schupp is commanding, thorough, meticulous, timely, and insightful. CMC Turnkey Solutions has been indispensable in the execution of my project
Martin Uram, MD, MPH, American Genomics
I first began working alongside CMC Turnkey consultants Barb Berglund and Audrey Schupp two years ago. They exhibit professionalism, high technical understanding, on time delivery, and strategic thinking suggestions for pharmaceutical development challenges. An absolute pleasure to work with! Highly recommend this team for your pharmaceutical needs.
Eileen Zilli, Independent Consultant
PharmaLogic has worked with CMCTKS starting in early 2018 on numerous ophthalmic investigational products – from anterior to posterior segment. This work included product development and manufacture, face-to-face regulatory meetings, and regulatory filings. I highly recommend CMCTKS for a broad range of CMC support.
Gary Novack, PhD, PharmaLogic Development, Inc
CMCTKS has been both a committed and truly excellent partner to work with through our pre-clinical and clinical development program. I do not think we would be where we are without their help and their key ability to understand the importance of stage-appropriate biotherapeutic design based on where a company is in their drug development program. From a small startup perspective, this has been indispensable especially when dealing with tight timelines and budgets. Thank you CMCTKS for helping to make our program our best!
Brian Lawrence, PhD, SilkTech Biopharmaceuticals
We understand the path from GLP to GMP and can set you up for success as you make the leap to clinical trials.
We understand critical change in formulation, presentation, and dosage. We support manufacturing and analytical testing. We can help assure quality products and a sound regulatory submission.
REGISTRATION AND VALIDATION
We bring strength to building your regulatory strategy and will be there as you move toward commercial processing.
We help identify continual improvement opportunities and stand by your side during manufacturing to assure safe and effective products are on the market.
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Please contact us with your questions and needs. Describe your situation and let us help you stay on the path for success.