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RA & PhV

Are you ready? Have you implemented EU ISO IDMP standards for medicinal products?

Are you ready to implement the EU ISO IDMP standards for medicinal products? Discover with us how to safely move to the new standards

RA & PhV

The EU Road to reach interoperability across regulatory systems: are you in step with the new EMA standards and regulatory systems?

The Life Science industry revolution goes along with the development of data interoperability systems that allow shared data within the entire.

RA & PhV

Food Supplement notification procedure changes

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

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.

RA & PhV

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.

RA & PhV

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.

RA & PhV

Pharmacovigilance Data: challenges for Pharmaceutical Companies

Data format, data location and data migration are recurring topics for Pharmacovigilance departments nowadays, learn more about the challenges to.