Blog

This post examines the crucial impact quality culture has on individuals, organizations, and processes; it offers tips for improving it in your company.

An efficient control strategy will ensure your processes performs always as expected. In this blog post we described the steps to design one.

This a story about how we helped a company with their biosimilarity assessments and to avoid massive time-to-market delay!

Today we want to take a fresh look into comparability for post-approval changes. How? We're thinking of a unique multiparametric approach.

This time we tell you how we helped a company finding a root-cause in a Filter Clogging and how we solved it.  

A story about this time we helped a company in the Post-Approval Change Management of a Legacy Product using a Retrospective QbD methodology.

In this blog post we explore the topic of minimising the subjectivity in Risk Assessments through Digitalisation of processes.

This blog post goes over the key aspects of developing solid comparability studies on early development stages.

Many medical device companies have struggled with implementing a risk management process that results in risk being mitigated to the level of AFAP.

The ICH released a draft version of the new ICH Q14 Guideline last March. This blog post will give you an overview of its key implementation aspects.

Learn how we helped a customer find the root cause of a problem in monoclonal antibody (mAB) production and become stronger.

There's a need to accelerate pharma product development and process scale-up. Having an effective tech transfer strategy can help you.

An important, and sometimes challenging, step in every product lifecycle is the point when it gets its premarket or a postmarket regulatory approval by the FDA. Luckily, through a combination of good practices for Benefit-Risk Assessment and technology, this has become much easier.

In this blog post, we’ll go through some concepts on Knowledge Management and the starting points for its implementation.

A light story about how ValGenesis joining on a quest to optimize a stage in a process, how did we do it and what came out of it.