Shavit Fragman is a certified quality systems auditor.
We perform audits per customer needs to inspect compliance with Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), SOP's, adherence to quality agreements, Pharmacovigilance.
Auditing include suppliers / vendors (mock Pre Approval Audits as well general GMP assessments) for Active Pharmaceutical Ingredient (API) and Dosage Form Manufacturers, Excipient Suppliers, Packaging component vendors, and GMP Service Providers.
Due diligence audits for general GMP and capacity assessment.
Our reports include CAPA recommendations.
Quality Agreements: Evaluation, preparation and related negotiation between parties.
SOP's - we offer review and design of SOP's.