Latest Insights

Medical Device

New Trends in Guidelines for Continuous Process Manufacturing

The importance of Continuous Manufacturing (CM) and its different approaches. The new guidelines and trends of continuous manufacturing explained.

GxP Compliance

Deviation Management

The deviation management process is a requirement and is designed to be a part of the Quality Management System (QMS) imposed by all major GMP.

GxP Compliance

Method Development in the EU

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

Regulatory Affairs

European Medicines Agency Guidelines for the Environmental Risk Assessment of Veterinary Medicinal Products (VMPs)

The European Medicines Agency (EMA) has issued guidelines for the environmental risk/impact assessment (ERA or EIA) of veterinary medicinal products.

Medical Cannabis

Legislative panorama: Focus on Portugal

What is the current legislative situation in Portugal related to Medical Cannabis

Pharmacovigilance

Why Pharmacovigilance is Important for the Veterinary Surgeon and Industries?

Pharmacovigilance system for the Veterinary Industries and that the compliance to the requirements requested by the EU regulations.

CSV & Data Integrity

ALCOA++: What’s New, What’s Important, and  What You Need to Know

What does the acronym Alcoa++ stand for?

Medical Cannabis

Genetic screening, personalized therapy and the importance of biomarkers in medical cannabis treatment

Can a treatment with cannabinoids be personalized?

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?

CSV & Data Integrity

How to Validate a Chromatographic Data System (CDS)

Understand the importance of Computerized System Validation and how it differs from Factory Acceptance Testing.