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Month: February 2021

MHRA Trial Master File (TMF) GCP Inspection Findings: Trends and Takeaways

On February 12, 2021, The UK Medicines & Healthcare Products Regulatory Agency (MHRA) published their annual GCP Inspections Metrics Report. This report covered the period

February 24, 2021

MHRA TMF Inspection Finding Checklist

Review tactics for preventing common eTMF Inspection Findings

February 23, 2021

FDA Removes Two-Way Communication from eCTD 4.0

FDA recently issued updates to their Electronic Common Technical Document (eCTD) v4.0 Technical Conformance Guide; FDA eCTD v4.0 Module 1 Implementation Package. The package was

February 2, 2021

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2025 in Review: AI, further simplifying compliance with our unified GxP platform, and many more

December 19, 2025

Introducing Ennov 11.0: AI-Powered Productivity for Regulated Teams

December 1, 2025

Ennov Successfully Completes eCTD 4.0 Submission with EMA – Giving Customers a Head Start

May 23, 2025

Ennov Completes the Enterprise Technology Integration from Calyx

June 3, 2024

Ennov Announces Strategic Acquisition of Calyx’s ‘Enterprise Technology’ Division

February 9, 2024

Ennov Boosts Portfolio with Acquisition of DocShifter: The Market-Leading Document Transformation Solution

February 9, 2024

Recent Posts

2025 in Review: AI, further simplifying compliance with our unified GxP platform, and many more

December 19, 2025

Introducing Ennov 11.0: AI-Powered Productivity for Regulated Teams

December 1, 2025

Ennov Partners with Matador to Bring Unified Life Sciences Solutions to Japan

October 1, 2025

Ennov User Meeting Europe 2025: Join Us in Paris This October

July 18, 2025

Ennov Ready to Support Customers in EMA eCTD 4.0 Customer Pilot Phase

July 9, 2025

Ennov Successfully Completes eCTD 4.0 Submission with EMA – Giving Customers a Head Start

May 23, 2025