Pharmaceutical Development & Manufacturing Services
We offer a complete range of analytical capabilities to support your requirements. Working in our dedicated 72,000 square feet of laboratory space, we have at present, over 30 projects in the development process.
Click Here To Download:
•Brochure: Alkermes Contract Pharma Services
Analytical Support
We offer a complete range of analytical capabilities to support your requirements. Working in our dedicated 72,000 square feet of laboratory space, we have at present, over 30 projects in the development process.
Specialized Development Services
We are a leader in specialized development services with a broad platform of patented drug optimization technologies.
Registration Support
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.
Process Development and Optimization
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.
Technology Transfer
For seamless tech transfers we leverage product and process understanding, honed risk assessment, process modelling and optimized experimental approaches - thereby maximizing transfer effectiveness.
Click Here To Download:
•Brochure: Alkermes Contract Pharma Services