Our Services

EHKrohl offers in-depth assistance in determining and achieving compliance with FDA regulations and expectations with respect to GxP Practices.

• EHKrohl 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.

On-Site, Remote, Your Choice

• EHKrohl offers services, including project management assistance, 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 and remote staff training.
• Corrective action planning to bring your firm into full GXP compliance.