BioFourCe, LLC

BioFourCe, LLC is your global Compliance and Pharmacovigilance partner, providing solutions to complex GxP problems... anywhere you are. BioFourCe, LLC has an experienced workforce that is intimately familiar with the challenges faced by pharmaceutical and biotech, device and nutraceutical companies. We assess, identify, develop and implement turn key solutions with policies, procedures and training that fit your needs and your budget. We provide unique solutions, strategies and staffing for complex problems to our clients/partners across Pharma, Academia, Biotech, Device, and Nutraceuticals. Our areas of specialization include: Product Life Cycle Development Clinical Development - Phase 1-3b and PMS Business Development/Partnerships/Licensing Due Diligence Global Pharmacovigilance Risk Management Safety system validation (ARGUS/ARISg) Vendor management / Qualification Alliance management and partner agreements Medical and Regulatory Writing: IND, NDA, EU MAA, PSUR, DSUR, ISS, CSR, RMP, PV Master File Quality Systems, Audits (vendor, site and internal dept)