Latest Insights

Medical Device

Israel MDSAP Affiliate Membership

The Ministry of Health of Israel has just been included in the Medical Device Single Audit Program (MDSAP), what are the changes?

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.

CSV & Data Integrity

Regulatory Trends in Computer Systems Validation and Data Integrity: The Evolution of Gap Assessments, Remote Audits, Inspection Readiness and Remediation during the Covid 19 Pandemic

After Covid-19 Pandemic, with FDA almost set to start remote auditing, is your company inspection ready?

Annex 1

The new EU GMP Annex 1 - Environmental Monitoring Sampling Zones

How does the Annex I shape the Environmental Monitoring strategy in your sterile facility?

RA & PhV

Food Supplement notification procedure changes

Effective June 30, 2022, the registration procedure for Food Supplement notification in Italy has changed.

Medical Device

FDA’s Breakthrough Device Designation, Expediting Your Pathway to Market

The US Breakthrough Device Designation Program can help your company speeding up your Medical Devices development, assessment and review.

Medical Device

How could the Medical Device User Fee Amendment V Impact your MD company?

MDUFA V is the latest amendment to the to the MDUFA Act, and it could bring an exceptional growth to the MD Community in the US.

IT Operations

How to deploy a LIMS

LIMS solutions can help your business in reaching new levels of efficiency and automation in your laboratory.

IT Operations

Cloud Computing in a Regulated Environment

Regulated companies are moving to Cloud solutions to store data, improving their performance and capability, while keeping a careful GxP oriented.

RA & PhV

100 Generic Medicines Suspended due to Clinical Data Integrity: How to secure your business and ensure your clinical data is valid

EMA has recommended the suspension of around 100 generic drugs for Data Integrity and Reliability issues, with the consequence of repeating the.