BioFourCe
BioFourCe LLC specializes in global pharmacovigilance and clinical development, offering comprehensive solutions from early clinical development to marketing approval across North America, Europe, Latin America, Australia/NZ, and Japan. Their services include AE case processing, signal detection, CSR, PSURs/RMPs, PSMF, risk management, vendor oversight, and compliance with GVP and local regulations. Led by CEO Shelly Goodman, with over 25 years of experience, the company emphasizes a proprietary PVG Touchpoints program and turnkey vendor oversight to ensure robust and compliant pharmacovigilance systems.
Industries
Nr. of Employees
small (1-50)
BioFourCe
3037 Cypress Creek Drive East, Ponte Vedra Beach, Florida 32082, United States
Services
Preparation and ongoing maintenance of RMPs, PSUR/PBRERs, pharmacovigilance master files (PSMF), CCDS and global/local label management.
Auditing, vendor qualification, mock US/EU inspections and remediation services including CAPA development and management.
Mapping of organizational PV touchpoints and provision of a turnkey vendor oversight program that tracks key metrics and integrates CAPA management.
Preparation and ongoing maintenance of RMPs, PSUR/PBRERs, pharmacovigilance master files (PSMF), CCDS and global/local label management.
Auditing, vendor qualification, mock US/EU inspections and remediation services including CAPA development and management.
Mapping of organizational PV touchpoints and provision of a turnkey vendor oversight program that tracks key metrics and integrates CAPA management.
Expertise Areas
- Global pharmacovigilance
- Aggregate safety reporting and RMP/PSMF preparation
- Regulatory compliance across US, EU, Latin America, Australia/NZ and Japan
- Regulatory inspection readiness and CAPA remediation
Key Technologies
- Adverse event case processing workflows
- Signal detection and safety surveillance methodologies
- Aggregate safety report generation (PSUR/PBRER)
- Pharmacovigilance system mapping and touchpoint analysis