Skip to content

About Us
Solutions
- - - Industry Solutions
      
      Strategic and Scientific Consultancy
      
      Integrated Product Development
      
      Innovations to Market
      
      Post-launch Outsourcing
      
      Local Affiliate Services
      
      Business and Portfolio Mergers & Acquisitions
      
      Industry Sectors
      
      Biotech
      
      Pharmaceutical & Consumer Health
      
      MedTech
      
      Departments
      
      Services
      
      Research and Development
      
      Statistics and Data Science
      
      Market Access
      
      Patient Safety (Pharmacovigilance)
      
      Regulatory Affairs and CMC
      
      Quality Management and Compliance
      
      Training
      
      Research and Development
      
      Statistics and Data Science
      
      Market Access
      
      Patient Safety (Pharmacovigilance)
      
      Regulatory Affairs and CMC
      
      Quality Management and Compliance
Solutions
Insights
- - - News & Events
  - - Thought Leadership
  - - 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
Insights
- News & Events
- Thought Leadership
Digital Innovation
Careers
Contact Us
Global Reach

Blog & Articles related to Regulatory Affairs and CMC

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

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

9th 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

Blog & Article

Amid global regulatory complexity, Australia shines a light on convergence and collaboration

12th December 2023

Informationsbeauftragten

Blog & Article

Aufgaben und Voraussetzungen des Informationsbeauftragten im pharmazeutischen Unternehmen

6th November 2023

Blog & Article

Australian regulators are removing the requirement for packaging of injectable medicines to include hard copies of product information

10th July 2023

Blog & Article

Progress on the New Zealand Therapeutic Products Bill

23rd June 2023

« Previous Page1 Page2 Page3 Page4 Page5 Next »

Company

About Us
Corporate Social Responsibility
Sustainability
Management Team
Sectors

About Us
Corporate Social Responsibility
Sustainability
Management Team
Sectors

Useful links

Contact Us
Imprint
Data Protection
Terms and Conditions
UK Modern Slavery Act Statement

Contact Us
Imprint
Data Protection
Terms and Conditions
UK Modern Slavery Act Statement

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

Newsletter Sign Up

©2024 PHARMALEX GMBH. ALL RIGHTS RESERVED.

Linkedin-in Youtube

Start typing and press enter to search

Search...

Scroll to Top