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.
Key Challenges faced by Hugel:
- A limited understanding of safety system implementation
- Having a fully validated safety system ready in time to market the drugs
- End-user training for the system was required
What was achieved for the client:
- A timely delivery of the drug safety system
- A fully validated system as per GAMP 5 guidelines
- A 50% reduction in human effort for case processing
- A system for end-to-end case processing meeting regulatory compliance requirements
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