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.
A global large pharmaceutical company with presence in multiple countries, our client had 3000 products across 125 countries that require a medical response in 20 different languages.
Our client, a global generic pharmaceutical company with market alliance and presence in multiple countries had built their safety system on AERS legacy system in collaboration with multiple vendors. The construct of the global safety system had been done on the ‘need of the day’ basis and was maintained by a large pool of vendors.
Our client, a midsize specialized biopharmaceutical company is a global leader in their chosen area of therapeutics. As a fast-growing pharmaceutical company, our client had a number of molecules in clinical trials and sustaining the growth depended significantly on the efficient conduct of the trials by the CROs.
Our client, a global large generic pharmaceutical company safety database was built progressively over a period of time and increasing load of safety cases and global reporting requirements had an adverse impact on the efficient functioning of the database.