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Certification of your APIs or Excipients by the EDQM puts your company on the world map of the |
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pharmaceutical industry gives you an edge over your competitors, adds prestige,
and carries |
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weight in any part of the world. |
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Certificates are valid in 28 European Pharmacopoeia Commission member countries and |
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partially accepted in 18 observer countries. |
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One-time centralized approval, 5–year validity, substitute for European Drug Master Files. |
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Growth in market share, better price realization. |
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In-depth Data Audit and Estimate of total expenses to achieve Certification |
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cGMP Audits and Rectification of Deficiencies in Manufacturing Facilities, Operations, and |
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Documentation |
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Complete guidance on EU cGMP / ICH Q7 Compliance |
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Arranging Validation and Analytical Support Services |
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Preparation of Application Dossiers |
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Review of Application Dossiers prepared by your staff before filing |
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Preparation of Quality Overall Summary (EU Expert Report) |
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Filing of Applications at EDQM |
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Follow-up with EDQM until Certification |
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Response to Query Letters |
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Major / Minor Changes / Amendments |
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Renewal of Certification |
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Knowledge of existing regulations and procedures, as well as future policy shifts. |
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Insight into how regulatory agencies think and what data they will need to approve |
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specific products. |
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Extensive experience in handling many Applications and interacting with the EDQM. |
