Quality Assurance and Pharmacovigilance
Our experience in pharmacovigilance includes product complaint, adverse event reporting and drug recall.
FDA, state and local inspection preparation
Internal audits conduct and preparation
External audits conduct and preparation
Every pharmaceutical company can expect an inspection from the FDA, state and local agencies. Not only will SB prepare your quality system, so it can pass these stringent inspections, but we can be there for you during them.
We can conduct internal audits to discover what areas need attention at your facilities. For your suppliers, we can conduct external audits required by the FDA.