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  - - EU MDR Article 117: Are Our Remits Clear?
      
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      18th September 2025
      
      Establishing a therapy’s market access and commercial potential with early phase modeling
      
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      18th September 2025
      
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      Regulatory case study: Outsourcing excellence drives growth for specialty pharmaceutical developer
      
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Blog & Articles related to CMC Biologics

Blog & Article

Five key trends in CMC

27th February 2025

Digital Technology Pharma

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How digital innovation is transforming CMC

11th February 2025

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ARCS Takeaways: IVDR in an Australian Context

17th July 2023

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TGA updates its reclassification timelines

11th July 2023

EMA Blog Regulatory Affairs

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European Commission set to simplify EMA fees framework in major overhaul

30th January 2023

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Navigating New Digital Regulatory Requirements

7th February 2022

TGA accelaration

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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

COVID-19 Chains

Blog & Article

Resilience of Pharma Supply Chains and the Impact of Covid-19 Pandemic

17th May 2021

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Strategic and Scientific Consultancy
Integrated Product Development
Innovations to Market
Optimal Patient Access
Business and Portfolio Mergers & Acquisitions

Strategic and Scientific Consultancy
Integrated Product Development
Innovations to Market
Optimal Patient Access
Business and Portfolio Mergers & Acquisitions

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