Manual ICSR Migration from SRP Portal to PV Database
A biotechnology and biopharmaceutical organization focused on delivering affordable vaccines and essential medicines for global health programs partnered with Vigilare…
A high-priority engagement required the processing of over 3,000 regulatory cases within a stringent one-month timeline. Leveraging streamlined workflows, experienced…
Merging and Validation of 4000+ Duplicate Records to Master Valid Cases
A leading Indian multinational pharmaceutical company specializing in generics, APIs, and finished formulations identified over 4,000 duplicate cases through internal…
eCTD Publishing and Submissions For a US-based Pharmaceutical Company
Vigilare successfully managed the preparation and submission of a highly complex Module 5 involving extensive clinical and bioequivalence documentation. Despite…
A Complex ANDA Portfolio & Seamless Execution of 250 Successful USFDA Submissions
Effective lifecycle management across multiple approved ANDAs requires structured oversight of Annual Reports and post-approval changes. When reporting gaps and…
Accelerated Global Safety Database Implementation
A mid-sized U.S.-based pharmaceutical company approached Vigilare to rapidly implement a global safety database within an aggressive four-week timeline. The…
A Top 10 Global Biopharmaceutical Company faced increasing regulatory scrutiny and needed to strengthen its Pharmacovigilance (PV) quality systems worldwide.…
