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Highlights from the GMP market and Valicare

You want to know what is driving the industry and ourselves? We have compiled the recent news for you here.

29 Results found
Blog
Valicare strengthens CSV consulting team

Since August 1, Eng. Thomas W. Hoehle supports Valicare customers as Senior Consultant with his extensive experience and expertise in the field of ...

Blog
Robotics and automation for ATMPs

Robotics and automation offer groundbreaking manufacturing methods for ATMPs. ATMPs are achieving groundbreaking success in the treatment of ...

Blog
Do your methods comply with the new ICH requirements?

ICH Q2(R2) and ICH Q14 describe mandatory requirements for the development, life cycle and validation of analytical methods.

Blog
The first CRISPR/Cas9-based therapy has reached the market

The admission of Casgevy (Exagamglogene autotemcel) opens a new chapter in CRISPR/Cas9-based gene therapy and ATMP manufacture

Blog
Transferring novel therapies successfully to patients and market

"ATMPs" – a long way from development to clinical trial – here's how to get there safely! ATMPs (advanced therapy medicinal products) are considered ...

Blog
Prohibition of PFAS – Evaluate, assess risks, time to act

Valicare experts present solutions to you Per- und Polyfluoroalkyl substances (PFAS) are widely used in the pharmaceutical and biotech industry as ...

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Revision of Annex 1 - New approaches are required soon!

Get an overview about the most important upcoming changes The revision of Annex 1 of the EU GMP Guideline will be effective this year. It faces ...

Blog
SMEPAC Test to Measure the Tightness of Containment Systems

Working with highly active and hazardous drugs and ingredients requires evidence that the used containment systems are leak proof!

Blog
Computerized System Validation (CSV) – GAMP 5 Second Edition

2nd Edition of the GAMP 5 Guideline will address required changes in computerized system validation (CSV). Have you adopted the changes yet?

Blog
Celebrating 20 years of Valicare

From drug development to marketing authorization, Valicare supports chemical, pharmaceuticals and biotechnology companies around the globe.

Blog
New ICH Q14 Guideline: Analytical procedure development

Analytical procedure development: harmonization, development process as well as improvement of change management, approval and communication with ...

Blog
Revision of ICH Q9 (R1) Guideline on Quality Risk Management

Innovations in the implementation of risk management in the pharmaceutical industry: product availability, hazard identification, and attention to ...

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