Latest Insights

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.

Audits

GDP Audits

Learn about Good Distribution Practice (GDP) guidelines by EMA, and how GDP audits ensure quality and integrity of medicinal products throughout the.

Cybersecurity

Go beyond data integrity; Information chain management part two

Learn about the importance of contemporaneous, original, and accurate information, often overlooked in information systems.

Commissioning & Qualification

FAT and SAT: What is the difference and why are they so important?

Do you know FAT and SAT? Learn their differences, and why they are essential for demonstrating equipment quality, compliance, and performance.

Engineering

Application of Regulations to Facility Design: The GMP Review

Ensure cGMP compliance and efficiency with our essential GMP Review and learn how to optimize your production process with this necessary evaluation.

RA & PhV

Are your products correctly classified under Article 34, Reg. (EU) 2019/6?

The Committee for Veterinary Medicinal Products has released a new guideline on the prescription status of veterinary medicinal products.

Medical Cannabis

Legislative panorama: Focus on Switzerland

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

Cybersecurity

Go beyond data integrity; Information chain management part one

Read about how Industry 4.0 has redefined production and why Information Chain Management is crucial in today's market.