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 quality 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.
Mind Pharma provides Appointed Pharmacist , Responsible Pharmacist – Qualified Person (QP) & batch release , Qualified Person Pharmacovigilance (QP-PV) , Market access and Market Insight support and Medical Director services.
We also support establishing quality assurance system management, writing SOPs, audits, mock audits, quality and technical agreements.
Need more information? Contact us here.