GMP Services

GMP manufacturing and analytical services are carried out at Halo Pharmaceutical, Whippany, NJ, in seamless collaboration with ExxPharma, in a manner that functionally resembles two different departments of the same organization. Teams from both companies manage the technology transfer process and subsequent manufacturing of the clinical trial batches, with ExxPharma assuming primary responsibility for the technical aspects of the programs and Halo having primary responsibility for overall GMP requirements, including manufacturing, analytical testing, packaging and stability testing.

 

Halo has state-of-the art cGMP manufacturing suites, fully compliant cGMP analytical labs, and ICH stability stations, and has successfully hosted numerous international regulatory and FDA inspection teams as well as client audits. Our integrated teams of technical, quality and regulatory specialists work closely to ensure timely product development, manufacturing of clinical trial materials and regulatory submissions.

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