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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
Jordan eCTD
ASEAN eCTD
EAEU
Nees
NEES submissions are submitted to the following Region
Europe​
Australia
SPL
Structured Product Labeling is a Health Level Seven (HL7) standard based on Clinical Document Architecture
SPM
Health Canada announced Structured Product Monograph (SPM) which should be submitted in an electronic format
Labeling Artwork Services
Our Labeling Artwork Services focus on creating and managing high-quality, compliant labeling artwork for regulated products. We ensure that all artwork adheres to the necessary regulatory standards and guidelines.