Registration Support- New Drug Application
Our Regulatory Department has successfully assisted a number of companies with various applications to the regulatory authorities in the US, Europe and Japan.
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•Brochure: Alkermes Contract Pharma Services
Our Regulatory Department has successfully assisted a number of companies with various applications to the regulatory authorities in the US, 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.
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•Brochure: Alkermes Contract Pharma Services