A few products developed by GemVax were ready for marketing, but the organization did not have any safety system in place. They needed validated safety system to be implemented, in time, for marketing.
Hugel Pharma, a global biotechnology firm, had a few approved products that were ready for marketing. The organization, however, did not have a safety system in place. They were looking for a partner that could deliver a safety system in a timely manner.
Axis Clinicals, one of the largest full-service clinical/biopharmaceutical development provider, wanted to implement ClinSpark phase I automation system, to enhance its regulatory compliance. The system being GxP required a formal validation of implementation and conﬁguration.