Our Services

eCTD 

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We provide services for​

• USFDA 

• European Medicinal Agency              

• Health Canada

• GCC

• SAHPRA

• Swiss Medic

• TGA

• Thai Food and Drug Administration

Nees

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NEES submissions are submitted to the following Region

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• Europe​

• Australia

• GCC

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SPL

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Structured Product Labeling is a Health Level Seven (HL7) standard based on Clinical Document Architecture

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SPM

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Health Canada announced Structured Product Monograph (SPM) which should be submitted in an electronic format

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