Pharma Specialists

EDQM

Certificate of Suitability (CEP) Filing Process | EDQM

Navigating the complexities of the CEP filing process can be dau…

May 21, 2024

API

Top 10 Deficiencies in New Applications for CEP for Chemical Purity

From this article you can learn how to avoid top 10 deficiencies…

March 05, 2024

EDQM

Pharma Euro Progress in the Field of Homoeopathic Manufacturing Methods

EDQM announced the progress made in 2023 on European Pharmacopoe…

February 09, 2024

EDQM

New General Chapter on Comparability of Alternative Analytical Procedures | EDQM News

A new general chapter, Comparability of alternative analytical p…

February 04, 2024

EDQM

New Requirements for the Content of the Chemical Purity | CEP 2.0

The European Directorate for the Quality of Medicines & He…

November 26, 2023

APIC

Active Substance Master File (ASMF) Certificate

The lifecycle of a European ASMF is often complicated, especiall…

August 22, 2023

EDQM

Applications for Certificates of Suitability (CEP) | Top Deficiencies

During the processing of an application for a Certificate of Sui…

August 09, 2023

EDQM

EDQM CEP is now named as CEP 2.0

CEP stands for Certification of suitability to the monographs o…

March 28, 2023

APIC

European Active Substance Master File (ASMF) Single Assessment | APIC Position Paper

Active Substance MasterFile (ASMF) or Drug master file (DMF) or …

February 16, 2023