Latest Insights

GxP Compliance

Method Development in the EU

Method development as a key process to encompasses the process of establishing chemical analytical techniques.

GxP Compliance

Entering the EU Market of generics: products’ registration, do’s and don’ts

How to register a generic medicine in the European market?

GxP Compliance

Requirements of an EU PV system – Signal Management

Signal management is complex and requires a customized approach to each product. Read this article to optimize your signal management strategies with.

GxP Compliance

What is a Stability Study and why is it important?

Are you interested in learning about stability studies and their critical role in the manufacturing process of new products?

GxP Compliance

Importation of Medicinal Products into the European Union

Are you looking to expand your drug products into the European market? Let us guide you through the process with a detailed overview.

GxP Compliance

EU product Registration Road Map

A number of processes must be completed by the manufacturing company in order to receive EU certification for its product. Are you aware of them ?

GxP Compliance

Do you know the 3 most important focal points of your technology transfer?

Read insight from our expert to learn more about most important aspects of technology transfer processes in the pharmaceutical landscape.

GxP Compliance

Biotech Products and the Challenge of Next Generation Cleaning Strategies

Cleaning Validation for Biotech products: our expert Marco Paolillo addresses the main challenges in the process.

GxP Compliance

What’s the “Cleaning Meaning”? The “5 Ws” of Cleaning Validation

Cleaning Validation in the Pharmaceutical Industry: our expert Marco Paolillo addresses the 5Wsv to avoid contamination and cross-contamination.

GxP Compliance

POINT OF CARE MANUFACTURE (POC): a new emerging model for innovative products

The Point of Care is a new approach for which drugs production sites should be as much close as possible to patients, to reduce the product lead.