REGULATORY AUDIT REMEDIATION
Has your organization received a FDA Warning Letter, or threatening to place your organization under a Consent Decree? If you are in a challenging position with the FDA, we are here to help. Effectively responding to these regulatory deficiencies requires cohesive planning and thorough documentation. Synergy Bioscience can help you assemble a complete FDA response package. Out auditors and consultants have comprehensive experience with the processes and procedures related to compliance with the US FDA regulations, as well as Canadian, European, British, Australian, Japanese, and ISO requirements. Experienced professionals at Synergy Bioscience will partner with you to help revamp and resolve deficiencies in your Quality System. These experts are capable of providing pre‐inspection audits for all functional areas and can assist with the remediation of formal inspection findings such as FDA 483, warning letter, consent decree, application integrity policy (AIP), and notified body review report.