Pharma Specialists

Pharma News

10 Changes in the New PIC/S Validation Guideline (PI 006-4)

Here are the changes that will have the biggest practical impact…

August 08, 2026

Pharma News

USFDA GDUFA User Fee Rates for FY 2027 | Key Takeaways & Trends

The US FDA officially announced the updated Generic Drug User Fe…

July 30, 2026

Pharma News

Top 10 Indian Pharmaceutical Companies and Their Contributions

Here are 10 Indian pharmaceutical companies known for their cont…

February 04, 2026

Pharma News

Top 5 Online Learning Platforms for Pharmacists

In 2026, the pharmacy profession is undergoing a massive transfo…

January 26, 2026

Pharma News

Top 15 Generic Drugs in Bangladesh 2026

Based on IQVIA 3Q MAT 2025, top selling 15 generic drugs in Ban…

January 16, 2026

EMA

Stability Testing for Marketing Authorisation Variations

The EMA has released a revision to the Guideline on stability te…

December 15, 2025

Pharma News

FDA Good Review Practice: Refuse to File (RTF)

The FDA has released an updated Good Review Practice (GRP) guida…

December 13, 2025

Pharma News

Physico-chemical and Biological Proficiency Testing Scheme (PTS)

The Proficiency Testing Scheme (PTS) is a form of external asses…

July 31, 2024

FDA

Standard for Uniform Blood and Blood Component Container Labels

FDA is issuing this guidance for immediate implementation in acc…

May 10, 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

EMA

Plasma Master File Certificates | EMA Regulatory Update

The plasma master file (PMF) is a compilation of all the require…

January 14, 2024

Pharma News

Falsification of Medical Devices | Results of European Survey

The falsification of medical devices is a serious international …

December 24, 2023

Medical Device

International Consensus Standard for Medical Device Manufacturers

After years of waiting, the FDA has finally sent its QMSR final …

December 08, 2023

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

EMA

First Electronic Product Information (ePI) Published for Selected Hhuman Medicines

The Heads of Medicines Agencies (HMA), the European Commission…

November 10, 2023

Pharma News

Recent Revision of EMA Nitrosamine Guideline | 2023

Most awaited revision (ver 16) of EMA nitrosamine guideline is p…

July 07, 2023

Pharma News

Identifying Trading Partners Under the Drug Supply Chain Security Act

The Food and Drug Administration (FDA) is issuing this guidance …

June 26, 2023

Clinical Trials

GCP Guideline on Computerized Systems and Data Integrity

Following the draft guideline published in June 2021 the final E…

June 18, 2023

AI

Artificial Intelligence and Machine Learning in Drug Development and Manufacturing

Recently FDA releases two discussion papers to spur conversation…

May 12, 2023

EDQM

EDQM CEP is now named as CEP 2.0

CEP stands for Certification of suitability to the monographs o…

March 28, 2023