Audits - Accurate Consultants are recognized as expert third-party auditors. We provide the correct balanced and perspective by providing both industry experts and former FDA Investigators to perform audits.
Mock FDA Audits - We provide the experts to perform mock FDA audits both domestically and internationally. We understand FDA various approaches and techniques and are able to identify significant compliance gaps and segregate the issues risk. We provide executive management audit reports, which highlight both risk and recommend corrective actions.
Regulatory Gap Analysis - Accurate auditors provide a comprehensive audit of the firm’s quality system and operation to identify gaps to the appropriate regulations and requirements.
Internal and External Supplier Audits - We provide the experts to plan and perform both internal CGMP audits and external supplier audits.
All audits will involve several steps including audit preparation, implementation, reporting, completion and follow-up if required. Audit reports include executive summaries, findings compared to requirements, regulatory significance, and recommendations of corrective action.
FDA Trouble Shooting - Our goal is to properly analyze, mitigate, and resolve FDA issues.
483 and Warning Letter Responses: Accurate FDA Consultants is highly experienced in responding to both FDA 483 and Warning Letters. We assess the situation and assist our clients in delivering the appropriate response for the situation. Accurate Consultants has been involved in successfully resolving over twenty Warning Letter cases.
Corrective Action Plans:In order to satisfy FDA and assure that the client meets all regulatory obligations according to schedule, we help develop comprehensive corrective action master plans. This is very effective in resolving any non compliance scenario.
Contact us today for a non-obligatory consultation and quote. Let’s discuss your needs and scope of your specific compliance project and requirements.
- Enterprise Risk Strategy and Emerging Technologies to address critical needs
- 3D Printing Medical Device Manufacturing= Additive Manufacturing
- FDA Issues New Import Data Requirements
- Compliance Dates for UDI Regulatory Requirements
- Strategic and Effective FDA Pre-Submissions
- Addressing FDA Import Alert and “Notice of FDA Action”