Category: Regulatory

The Regulatory category focuses on the frameworks and requirements that guide the development, manufacture, and distribution of pharmaceutical products worldwide. Regulatory oversight defines how companies demonstrate quality, safety, and efficacy while staying aligned with evolving global expectations.

Topics include regulatory submissions, variations, renewals, lifecycle management, labeling, pharmacovigilance, and risk assessments, with attention to strategy and regulatory intelligence.

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IDMP Ontology what is it and how to use it in your organization - featured image

IDMP Ontology: What It Is and How It Can Be Used in Your Organization

IDMP Ontology explained: how it supports regulatory data, improves data governance, and prepares your pharma organization for SPOR and ISO...
GMP vs GLP - 10 Key Aspects for Quality and Compliance

GMP vs GLP: 10 Key Differences for Quality and Compliance

Explore the key differences of GMP vs GLP and how these practices warrant the highest industry standards....
Pharmacovigilance

Pharmacovigilance – Ensuring the Safety of Medications

Explore the crucial role of pharmacovigilance in ensuring medication safety, from detecting adverse effects to proactive risk management....
Defining Specification Limits for Unknown, Known and Total Impurities in New Drug Products with HPLC

Defining Specification Limits for Impurities in New Drug Products

Learn how pharmaceutical manufacturers define specification limits for known, unknown, and total impurities in new drug products, ensuring safety and...
GMP Regulatory Bodies

GMP Regulatory Bodies: Understanding the Key Differences

Explore global GMP standards with regulatory bodies like FDA, EMA, and WHO. Ensure compliance for pharmaceutical quality and safety worldwide....
GxP - Person working in laboratory

Understanding GxP Regulations in The Pharmaceutical Industry

Navigate success in the pharmaceutical industry with GxP compliance. Explore GMP, GLP, GDP, and GCP for quality, safety, and regulatory...

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