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  - - What’s new in ICH Q2(R2) ? The Enoval software can help you be compliant !
      
      Blog & Article
      
      18th April 2024
      
      Centralize, Modernize, Harmonize: The Acceleration of Regulatory Digital Trends
      
      Journal Article
      
      27th March 2024
      
      Clinical trials regulation (CTR)
      
      Infographic
      
      Exploring the interactions between validation and technology transfer
      
      Podcast
      
      7th February 2024
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Global Reach

Blog & Articles related to eCTD, System Operations and Data Management

Blog & Article

ARCS Takeaways: IVDR in an Australian Context

17th July 2023

Blog & Article

TGA updates its reclassification timelines

11th July 2023

EMA Blog Regulatory Affairs

Blog & Article

European Commission set to simplify EMA fees framework in major overhaul

30th January 2023

NMPA’s e-submission in China

Blog & Article

Unpacking the NMPA’s draft guidelines on e-submission in China

16th November 2022

NMPA electronic submissions China

Blog & Article

China’s NMPA announces plan to require electronic submissions from December 1

11th November 2022

FDA

Blog & Article

Preparing for Success – How to have a positive FDA Inspection

2nd September 2022

Blog & Article

Navigating New Digital Regulatory Requirements

7th February 2022

TGA accelaration

Blog & Article

TGA looks to comparable overseas regulators to speed up access to new medicines

15th November 2021

Mask Air Pollution

Blog & Article

Gas Pathways – ISO 18562 progress

20th August 2021

Digital Transformation

Blog & Article

At Last Digital Transformation is Embraced by the Healthcare Industry

19th August 2021

Titanium Dioxide

Blog & Article

Titanium dioxide declared unsafe in food products

4th August 2021

Blog & Article

The bio pharmacy: market authorisations for protein-based medicines

12th July 2021

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Solutions

Strategic and Scientific Consultancy
Integrated Product Development
Innovations to Market
Post-launch Outsourcing
Local Affiliate Services
Business and Portfolio Mergers & Acquisitions

Strategic and Scientific Consultancy
Integrated Product Development
Innovations to Market
Post-launch Outsourcing
Local Affiliate Services
Business and Portfolio Mergers & Acquisitions

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