Compliance Solutions

» Audits - Our 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 - 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: FDA Consultants are 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. Our Consultants have been involved in successfully resolving many 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.

We look forward to speaking with you about your specific project needs. Please use the Contact Us form so we can assign the right expertise for further discussion or for an immediate response call 800 782 0580.