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      Journal Article
      
      31st January 2023
      
      Managing the medical device pre-submission process with the FDA
      
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      30th January 2023
      
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Blog & Articles

In Vitro EU regulation

Blog & Article

Countdown for EU health institutions using in-house devices

30th January 2023

EMA Blog Regulatory Affairs

Blog & Article

European Commission set to simplify EMA fees framework in major overhaul

30th January 2023

Eilish Kelly Spotlight

Blog & Article

Eilish Kelly (Consultant/Manager, Quality & Compliance at PharmaLex)

13th January 2023

IVDR technical files

Blog & Article

Making technical files clear, concise and easy to navigate is key under IVDR

14th December 2022

FDA Chemical Risk Assessment Tools

Blog & Article

FDA Publishes Chemical Risk Assessment Tools (CHRIS)

7th December 2022

Bio Ateliar Take aways

Blog & Article

Biotech Atelier – Innovation and Regulations September 28, 2022

30th November 2022

Notified Body IVDR

Blog & Article

The challenge of finding and working with a Notified Body under the IVDR

28th November 2022

Brazil Blog

Blog & Article

Brazil’s resolution seeks to fast-track products approved by recognized health authorities

17th November 2022

NMPA’s e-submission in China

Blog & Article

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

16th November 2022

compliance pharma

Blog & Article

Quality Culture – “What’s Love got to do with it?”

16th November 2022

NMPA electronic submissions China

Blog & Article

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

11th November 2022

Outsourcing Pharma Blog

Blog & Article

New outsourcing trends take shape across the pharma industry

7th November 2022

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

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