CMO selection and oversight for Biotech products & Injectable drugs, both clinical and commercial products.

Examples of Services Provided :  with more than 15 years of CMO (Contract Manufacturing Organization) experience, AMS can help you to select the appropriate CMO for your project and establish a lasting and trusted  partnership.  Mr. Milligan was one of the principles involved in building and managing a well respected and nationally recognized aseptic pharmaceutical CMO business for the contract manufacturing of injectable drugs.  He understands all aspects of the CMO business for the injectable drug marketplace as he was an Operations Executive at 2 well known CMOs in the last 15 years;  Regulatory compliance, pricing, equipment and process technologies, documentation practices and more.

• Project management of a clinical or commercial product technical transfer into the CMO.
• CMO technical audit and support choosing the appropriate CMO for your needs.
• PIP (Person in Plant) responsibilities.
• Assessments of various domestic or international CMOs for the aseptic processing of liquid or lyophilized product in glass or plastic vials, syringes, or cartridges.
• CMO identification for phase I, phase II, phase III and commercial fill/finish.

Fulfill your company’s needs for both primary and secondary packaging requirements