Latest Insights

Regulatory Affairs

Reform of the pharmaceutical sector by the EU Commission

At the end of April 2023, the EU Commission announced the largest reform of the pharmaceutical sector in over 20 years. Why is this happening right.

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.

Regulatory Affairs

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.

Regulatory Affairs

Elemental Impurities in Veterinary Medicinal Product

In January 2023, the implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products will enter into.

Regulatory Affairs

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

Regulatory Affairs

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.

Regulatory Affairs

Food Supplement notification procedure changes

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

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.

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.

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.