Regulatory Operations: eCTD and Submissions news

eCTD transmissions | Australia

ASPHALION and its partner Extedo® can help you navigate your Australian submissions. We can support you in a variety of activities.


Amazing first day at the Global Pharmaceutical Regulatory Affairs Summit 2023 (GPRAS) in Brussels!! Asphalion experts Silvia


A lot of things have happened at Asphalion during these past three months, and we have summarized

US FDA | SD File

The SDF is an extensible, portable text file encoding computer-readable chemical structures linked to associated data fields.

FDA Study data

Are you planning to send a submission to the FDA? Will this submission contain study data? If

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