Latest Insights

Regulatory Affairs

Is your internal personnel and sales force adequately trained? And your pharmacovigilance staff?

Trained personnel play a vital role in ensuring medicinal safety in the animal health business. To achieve this, companies must focus on two primary.

Regulatory Affairs

Prevention and management of human medicinal product shortages in compliance with the recent EMA guideline on good practices for industry

2 of the 10 recommendations could be considered the main important to follow: they underline the importance to act preventing and to manage the.

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

Why Pharmacovigilance is Important for the Veterinary Surgeon and Industries?

Pharmacovigilance system for the Veterinary Industries and that the compliance to the requirements requested by the EU regulations.

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.