An important, and sometimes challenging, step in every product lifecycle is the point when it gets its premarket or a postmarket regulatory approval by a regulator. Luckily, through a combination of good practices for Benefit-Risk Assessment and technology, this has Read more…
Today, the pharmaceutical industry is facing a lot of pressure to meet the high demands of the customers and regulators. The market is rapidly changing and, as such, your product development needs to keep up with it. You can achieve Read more…
The acquisition introduces new product synergy across all stages of the validation lifecycle program. San Francisco, June 14th, 2022: ValGenesis, Inc., the market leader in enterprise Validation Lifecycle Management Systems (VLMS), has acquired Portugal-based 4Tune Engineering (4TE), a leader in manufacturing Read more…
The biosimilars market has always been of great interest. However, since 2019 this interest has increased even more, due to the published FDA guidance on demonstrating biosimilar interchangeability. And just like that, the quest for interchangeability began! Despite the need Read more…
This is a successful story about the application of the Quality by Design (QbD) framework in the development of a drug product. However, this time we’re not alone, as this was a joint project with Libbs Farmacêutica! Despite the well-known Read more…
When we discuss Quality Risk Management, we often focus on the operation, shop floor side of the processes. Today we’ll talk about some of the key aspects of QRM for the top-tiers of the Pharmaceutical Companies and how bringing the Read more…
The success of a globalisation strategy relies on a key pillar: process and product performance comparability. This is so because global pharma companies require flexibility to produce the same product across a network of manufacturing sites and locations. For this blog post, Read more…
Cell and Gene Therapy (C>) is a fast-growing field, and that fast growth brings challenges to its development and manufacturing process. Implementing Process Analytical Technology (PAT) and Quality by Design (QbD) might be the answer to overcome some of those Read more…
Recent world events have been showing pharma companies the importance of having an effective business continuity plan (BCP). Risk management is a crucial part of the business continuity plan, but it can be a challenge for the pharma industry, given Read more…
The last few years have been full of advances in the field Advanced Therapy Medicinal Products (ATMPs). And, as any products that interfere in the health and well-being of patients, it requires a Quality Risk Management System. Which brings us Read more…