As important as regulatory compliance is, many struggle to fully understand, and adhere to, the vast scope of the guidelines and recommendations set forth by governing bodies. One of Bioviser’s clients experienced a similar struggle in meeting and managing global regulatory and safety requirements. Eventually, the client, located in a gulf country, decided to contract a vendor proficient in pharmacovigilance, and Bioviser was introduced to the internal team as a PV monitor helping bridge the gap and overseeing the observance of safety standards.
APPROACH
With no time to spare, Bioviser consolidated a 4-member team in Hyderabad, India, to execute the invigilation process, and set up a special team to offer client servicing support during operational hours in the gulf country. Bioviser’s team instituted a PV system and a complementary QMS. Further, a literature search engine along with a clearly outlined adverse event reporting system was founded. Standardized report templates were additionally created for distributing aptly formatted documents among various competent authorities.
As part of its initial association with the client, Bioviser was required to submit deliverables across markets and licensing partners. To ensure an effective output, recurrent discussions were held and any kinks concerning communication, expectation mismatch, and capacity planning were ironed out. Bioviser also performed the ICSR processing for literature cases, and the complexity of documentation included all types of aggregate reports for all markets.
