Regulatory Services Pre-Submission Services
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Registration and self-identification i.e. D-U-N-S number, FEI number request
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Compilation and Investigational New Drug - IND Application
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Compilation and New Drug Application - (NDA)
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Compilation and Abbreviated New Drug Application (ANDA)
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Compilation and Investigational Medicinal Product Dossier (IMPD)
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Marketing Authorization Application (MAA) to Europe via appropriate procedure
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MAAs for Biosimilar product
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Certification of suitability for EU
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Dossiers for emerging countries (RoW market)
