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EHK offers in-depth assistance in determining and achieving compliance with FDA regulations and expectations with respect to Good Clinical, Good Laboratory, and Good Manufacturing Practices.

EHK can facilitate approval of product applications by:

• Performing mock FDA pre-approval inspection audits.
• Serving as your firm's representative to the FDA.
• Participating in on-site FDA inspections.
• Analyzing and preparing FDA 483 responses.

EHKrohl Consulting, Inc. offers services, including project management, for:

• Review of regulatory applications, process validation, operations and procedures. Auditing of GLP / GMP systems and data.
• Auditing of clinical data, investigator sites; IRB and CRO assessments.
• Perform "due diligence" audits for selection of contract manufacturers and corporate purchasing decisions.
• Computer system validation review including CANDA and database auditing.
• Analysis, development, and documentation of Standard Operating Procedures.
• Analysis and development of the Quality Assurance audit function.
• On-site staff training.
• Corrective action planning to bring your firm into full GXP compliance.