EVENT | GPRAS 2023

October 23, 2023

| Data Management, Regulatory Operations: eCTD and Submissions

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

Asphalion experts Silvia Santos, Beatriz Ugalde, Daniel Langa and Helen Chen await you at booth #4 to help you in all your Data, eSubmissions and Regulatory requirements!

For further information, contact us at: [email protected]

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NEWS | Release of EU eCTD Module 1 Specification v3.1.1 and Validation Criteria v8.2

June 10, 2025

We are pleased to announce the publication of the updated EU eCTD Module 1 Specification version 3.1.1, along with the corresponding Validation Criteria version 8.2,

EVENT | RAPS EuroConvergence 2025

May 9, 2025

At ASPHALION we are pleased to announce our participation in RAPS EuroConvergence 2025, one of the premier regulatory affairs events in Europe. This year’s conference

TGA Updates eCTD Module 1 Specification to Version 3.2 | Effective April 2025

April 23, 2025

The Therapeutic Goods Administration (TGA) of Australia has released an updated version of its electronic Common Technical Document (eCTD) Module 1 Specifications, moving from version

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NEWS | Release of EU eCTD Module 1 Specification v3.1.1 and Validation Criteria v8.2

EVENT | RAPS EuroConvergence 2025

TGA Updates eCTD Module 1 Specification to Version 3.2 | Effective April 2025

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EVENT | GPRAS 2023

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Related news and events

NEWS | Release of EU eCTD Module 1 Specification v3.1.1 and Validation Criteria v8.2

EVENT | RAPS EuroConvergence 2025

TGA Updates eCTD Module 1 Specification to Version 3.2 | Effective April 2025

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