Our highly experienced and accomplished scientists and support staff participate in an open and team-focused environment in the development, scale-up (and tech transfer) of your products. We actively encourage partner participation throughout the process to successfully achieve your project goals.
Alkermes Contract Pharma Services is a leader in specialized development services with a broad platform of patented technologies. For more information on our unique drug delivery capabilities please click here.
Alkermes Contract Pharma Services offers a complete range of analytical capabilities to support your requirements – be that technology transfer, scale-up, clinical trial supplies or full scale commercial manufacturing. Working in our dedicated 72,000 square feet of laboratory space, we have at present, over 30 projects in the development process.
A process improvement culture has been embedded in our development facilities with our scientists actively recommending ways to improve development and production methods that can potentially reduce partner risk and also improve efficiencies.
Our Regulatory Department has successfully assisted a number of companies with various applications to the regulatory authorities in the U.S., Europe and Japan. We provide assistance to our partners with the preparation of New Drug Applications and updates, Investigational New Drug Applications, Drug Master files and post-marketing supplements. We maintain site reference files and authorized access to drug master files as needed. Our quality group holds the responsibility of releasing our partners’ batch records and undertakes this according to internal standard operating procedures and cGMPs.
For seamless tech transfers we leverage product and process understanding, honed risk assessment, process modeling and optimized experimental approaches - thereby maximizing transfer effectiveness.
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