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  - - Tackling challenges with nitrosamine risk assessment
      
      Blog & Article
      
      16th 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 Agency Interactions

Blog & Article

ARCS Takeaways: IVDR in an Australian Context

17th July 2023

Blog & Article

TGA updates its reclassification timelines

11th July 2023

Europe Regulation

Blog & Article

Proposed EU pharmaceutical legislation to bring significant revisions

5th June 2023

Brazil’s ANVISA puts medical device industry on notice with updated legislation

Blog & Article

Brazil’s ANVISA puts medical device industry on notice with updated legislation

27th February 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

UK MedTech Regulation

Blog & Article

MHRA updates on the future UK Medical Device Regulation

31st October 2022

Medical Devices Tenders Hong Kong

Blog & Article

New government tender requirement for medical devices in Hong Kong – Revised version 06/14/2023

26th October 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

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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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