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Our Manufacturing domain handles a comprehensive set of services that can deliver toxicology test article, API, and clinical trial material supplies, and registration and commercial product batches. Our network of prequalified resources using PharmaDirectNet®, allows us to work with your schedule without boundaries of capacity or capabilities. All of our staff have proven experience not only in manufacturing, but also across the drug development lifecycle. Our multi-disciplinary teams seamlessly manage drug supply needs in the midst of a changing landscape of variables from the clinical study design and schedules, vendor availability and packaging and labeling requirements, thus saving you time and money along the drug development path.
Our staff prepares or reviews critical development reports and other CMC reports along the way to expedite compilation, review and NDA submission for commercial approval.
Key Benefits
Match vendors with expertise best suited for each program
• Keep a pulse on vendor schedules for capacity, timing and responsiveness
• Assure quality and compliance with seasoned auditors and by arranging pre-established agreements
for quality and service
Quick project start-up leading to faster output of drug product
•Little or no lag time between development phases by utilizing vendor network
•Streamlined processes and prior experience with vendors leads to time-efficient technical transfers
• Project planning and project execution employing a comprehensive list of sequentially factored predetermined tasks
Flexible response to changes in formulation during manufacturing process
•Multidisciplinary teams comprised of manufacturing, formulation, quality and analytical experts can respond to virtually any unforeseen obstacle
Teams seamlessly manage manufacturing schedules regardless of outside variables
•Changes in clinical program that require different amounts of supplies, additional packages and/or dose strength changes are managed without schedule delays
•Interruption at any specific vendor can be accommodated by transfer to other similar vendors in our network
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