Latest Insights

FemTech

FemTech: lab quality diabetes detection, at home

After Gestational diabetes mellitus (GDM), 50% or more of mothers develop type 2 diabetes within 5-10 years and children have an 8-fold increased.

GxP Compliance

Manual Visual Inspection

Manual visual inspection in pharmaceutical manufacturing is a critical process that requires careful risk assessment and mitigation. The FDA and.

FemTech

Revolutionizing Women's Healthcare in India: The Rise of FemTech

In India FemTech is playing a pivotal role in transforming women's healthcare, making it more accessible, personalized, and empowering than ever.

Medical Cannabis

Legislative Panorama: Focus On Netherlands

What is the current legislative situation in Netherlands related to Medical Cannabis?

GxP Compliance

Blockchain GAMP5 10

Blockchain technology can enhance compliance in the pharmaceutical field. What is the connection and how you can apply blockchain to your business?

Regulatory Affairs

Environmental Risk Assessment of Medical Products for Human Use: Comparison between EMA & FDA Requests

The important role of Environmental risk assessment (ERA) before applying for marketing authorization in Europe and in the United States.

Pharmacovigilance

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.

Medical Cannabis

Production according to GACP and GMP (2/4)

Second edition, on the importance of Quality Control of the cultivation conditions, to guarantee a reliable and consistent end-product.

CSV & Data Integrity

Begin with the End in Mind: Back to the Focus of Quality - About the Application of GAMP5 Ed02 in CSV Projects

The best way to apply the GAMP5 second edition in CSV Projects - Begin with the End in Mind

Annex 1

Contamination Control Strategy: a Guide through the Road for its Preparation

The Contamination Control Strategy plays a vital role in the framework of the revised EU GMP Annex 1, encompassing critical control points and.