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Supplying to customers in these markets 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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Penetrating these high entry-barrier markets means lesser competition, better price |
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realizations, and long-term profits. |
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cGMP Audits and Rectification of Deficiencies in Manufacturing Facilities, Operations, Quality |
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Systems, and Documentation. |
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Complete guidance on ICH Q7 / US FDA / EU / TPD cGMP Compliance |
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Arranging Validation and Analytical Support Services |
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Preparation of DMFs / Review of DMFs prepared by your staff before filing |
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Preparation of Quality Overall Summary / EU Expert Report |
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Appointment of Regulatory Agent(s) |
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Submission of DMF / EDMF |
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Sponsor Identification |
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Letters of Authorization / Access |
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Liaison with US FDA / TPD / EU Authorities / Regulatory Agent(s) |
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Pre-inspection cGMP Audits |
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Response to Deficiency Letters |
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Annual Reports (USA), Major / Minor Revisions and Updates |
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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 interacting with regulatory agencies in the USA, Europe, and Canada. |
