- 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.