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Presence in these markets puts your company on the world map of the pharmaceutical |
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industry and gives you an edge over your competitors 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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You will find it easier to gain entry into many other countries that insist on allowing only |
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imports of products that have been previously approved in these markets. |
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Information on Reference Drugs and Acceptable Generic Equivalents. |
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Assistance in procurement of Reference Drug Product Samples. |
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Locating DMF / CEP / COS sources for Active Ingredients, Packaging Materials, Excipients. |
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Preparation of DMFs for client’s own API(s). |
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cGMP Audits and Rectification of Deficiencies in Manufacturing Facilities, Operations, |
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Quality Systems, and Documentation. |
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Complete guidance for US FDA / TPD / EU Regulatory Compliance. |
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Complete guidance for preparation of ANDA / ANDS / MAA Documentation. |
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Arranging Validation and Analytical Support Services. |
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Arranging for Bioequivalence Studies acceptable to US FDA / TPD / EU Authorities. |
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Preparation of Quality Overall Summary, Non-Clinical / Clinical Overview, Non-Clinical / |
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Clinical Summary / EU Expert Reports. |
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Pre-inspection cGMP Audits. |
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Appointment of Regulatory Agent(s). |
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Submission of ANDA / ANDS / Abridged MAA. |
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Liaison with US FDA / TPD / EU Authorities / Regulatory Agent(s). |
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Response to Deficiency Letters. |
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Supplementals / Variations / Amendments to Applications. |
