Latest Insights

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.

Regulatory Affairs

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.

Medical Cannabis

Conceptual Design for a manufacturing plant of cannabis based products

To guarantee high quality of standards in production, every investment in the medical cannabis production should take into consideration a.

Medical Cannabis

Medical Cannabis: Indoor Growing

Technologically up to date Greenhouse facilities, that respects the standards for medical cannabis production, ensure high productivity and.

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.

Engineering

Automation in the course of industrial transformation: automation added value to the Tobacco Industry

Industry 4.0 affects the whole industrial production, tobacco products included, bringing new challenges and improving production capacity and.

Regulatory Affairs

Are you really moving towards a GLocal Regulatory approach?

Project Orbis and other collaborative projects are shaping the future of Regulatory Affairs, helping patients by getting products to market in.

Next Generation Products

Synthetic Nicotine: Drug or Tobacco Product? Bill H.R. 6286 approval closes the loophole

A recent bill from the US Government closed the regulation loophole for synthetic nicotine, making producers review their strategy to access the.

Medical Cannabis

Medical Cannabis: Quality standards and evolution through scientific research

Medical Cannabis is going through a period of change in terms of culture and regulations, with countries that are now drafting or issuing new bills.

Regulatory Affairs

How the Regulatory Affairs Landscape can change in the post Covid-19 Era: the road so far and the emerging trends

Health Authorities collaborative projects in Regulatory Affairs are getting many attentions lately because of their speed in getting products to.