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  - - Understanding the requirements and nuances of sterility testing
      
      Blog & Article
      
      16th January 2025
      
      The Lifespan of Mature Drugs in 2025: Q&A with Kirsten Jacobs
      
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      20th December 2024
      
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Blog & Articles related to Regulatory Affairs and CMC - Page 2

Blog & Article

Vigilance guidance provides greater clarity on MDR requirements

29th May 2024

Clinical Evidence

Blog & Article

Opportunities and risks as biosimilars come of age

25th May 2024

Blog & Article

Why Access Consortium makes sense for industry and regulators

21st May 2024

Blog & Article

EMA’s eCTD 4.0 workshop seeks to gear industry for implementation

26th April 2024

UK MedTech Regulation

Blog & Article

The complex landscape of French regulatory affairs

25th April 2024

IRP and the Windsor Framework seek to ensure timely access to new medicines in the UK

Blog & Article

Tackling challenges with nitrosamine risk assessment

16th April 2024

Blog & Article

Handling substantial modifications under the CTR

14th March 2024

Blog & Article

CTR in focus: Staying ahead of the latest developments and new transparency rules

14th February 2024

Blog & Article

Hong Kong paves the way for mandatory regulatory framework for medical devices

13th February 2024

CTR in focus: Strategic planning to transition to the EU Clinical Trials Regulation

Blog & Article

CTR in focus: Strategic planning to transition to the EU Clinical Trials Regulation

8th February 2024

FDA takes steps to support novel therapy innovation

Blog & Article

FDA takes steps to support novel therapy innovation

8th February 2024

Blog & Article

Developments in Biocompatibility Standards

3rd January 2024

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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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