- Experienced auditors of raw material suppliers, API, contract manufacturers, test laboratories, and potential joint venture partners
- Fluent in German; ready to perform audits for you in Germany, Austria, Switzerland, and many other European countries.
- Experienced in etiquette and social expectations in Asian countries.
- We can execute an audit on your behalf, or lead members of your organization on an audit.
- Send your development scientist along as a subject matter expert; we train them while auditing.
- We identify strategic challenges, recommend solutions, and facilitate communications with your suppliers.
We can perform a mock inspection to prepare your staff for FDA, EMEA, or other regulatory authority.
- Staff development using a variety of scenarios. Group training and one-on-one interview practice.
- Post inspection review and management summary.
- Review of inspection SOP and document readiness.
- Logistical basics and audit etiquette, plus many other technical and non-technical aspects of an inspection.
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