In regulated markets such as the USA, Canada, and for products that are the subject of European Drug Master Files, manufacturers cannot market their APIs, Excipients, or Packaging Materials unless a dosage form manufacturer applies for an approval or authorization for a dosage form containing their API/Excipient/Packaging Material. Such dosage form manufacturers are generally referred to as
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A sponsor is the key to achieving entry into any of these markets. |
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The sponsor uses your API/Excipient/Packaging Material to manufacture a dosage form, and |
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triggers the first review of your DMF by the regulatory authorities. |
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The sponsor acts as the champion for your product, and guides it through the regulatory system. |
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Once a product has been approved by the relevant agencies, subsequent product approvals |
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with the same formulator or any other formulator using your API/Excipient/ Packaging |
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Material become very straightforward. |
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A powerful marketing tool to increase your market presence, to approach other potential buyers |
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all over the world. |
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Presence in the regulated markets results in higher sales volumes, better price realizations, |
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increases prestige and carries weight in any part of the world. |
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Extensive database of pharmaceutical companies, products and distributors in the regulated |
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markets. This database is continuously updated. |
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Personal contacts, experience of business dealings, ability to generate reliability data on |
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potential customers in worldwide markets. |
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We can ensure that sponsors provide information about brand names, product licenses, |
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commercialization dates – which are critical for obtaining Certificates of Suitability in Europe. |
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Strict confidentiality |