Calculation of limit when more than one nitrosamine is identified in the same product

Regulatory Affairs

Calculation of limit when more than one nitrosamine is identified in the same product

• October 25, 2026

Calculation of limit when more than one nitrosamine is identified in the same product   - Ensured that the total risk level of the sum of ...

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Establishment Acceptance Limit for Nitrosamine impurities

Regulatory Affairs

Establishment Acceptance Limit for Nitrosamine impurities

• October 23, 2026

Establishment Acceptance Limit for Nitrosamine impurities : Establishment of the AIs with The Carcinogenic Potency Categorization Approach...

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Nitrosamine risk assessment process:

Regulatory Affairs

Nitrosamine risk assessment process:

• October 22, 2026

  Nitrosamine risk assessment process: The nitrosamine risk assessment process is a systematic, multi-step framework required by global re...

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Introduction to Nitrosamines: Definition, Sources, and Risks

Regulatory Affairs

Introduction to Nitrosamines: Definition, Sources, and Risks

• October 17, 2026

Introduction to Nitrosamines: Definition, Sources, and Risks  𝑁 -nitroso compounds (-N 2 O) that can act as potent mutagenic carcinogens u...

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European Regulatory Affairs: Countries and Marketing Authorisation Procedures

Regulatory Affairs

European Regulatory Affairs: Countries and Marketing Authorisation Procedures

• October 14, 2026

European Regulatory Affairs: Countries and Marketing Authorisation Procedures Basic Concepts on European Countries European Union (EU) - 27 ...

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ICH Guidelines: A Quick Overview

Regulatory Affairs

ICH Guidelines: A Quick Overview

• October 14, 2026

ICH Guidelines: A Quick Overview The International Council for Harmonisation (ICH), a global non-profit organisation, is unique in bringing ...

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DMF vs CEP

Regulatory Affairs

DMF vs CEP

• October 08, 2026

DMF vs CEP DMF - Drug Master File CEP - Certificate of Suitability  DMF vs CEP: What’s the Difference?

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Types of Closures in Packaging

Packaging

Types of Closures in Packaging

• July 03, 2023

CLOSURES The closure is the most critical component of the package, as far as stability of the product is concerned. An effective closure sy...

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Responsibilities of Regulatory Affairs Professionals

Regulatory Affairs

Responsibilities of Regulatory Affairs Professionals

• April 19, 2023

The regulatory department is responsible for so many things. They have to ensure manufacturers comply with global regulatory requirements. R...

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Importance of Regulatory Affairs in Pharmaceuticals

Regulatory Affairs

Importance of Regulatory Affairs in Pharmaceuticals

• April 18, 2023

Importance of Regulatory Affairs in Pharmaceuticals Regulatory affairs play an important role in pharmaceuticals. It plays an important role...

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Graphical Abstract

Visual abstract

Graphical Abstract

• April 18, 2023

Nowadays graphical abstracts are getting popular. Many journals are increasingly requesting the submission of a graphical abstract or visual...

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