Regulatory Affairs Archives

Drugs serialization and barcoding in Saudi Arabia and MENA region

by Nick | Mar 11, 2021 | Regulatory Affairs

An increasing number of countries worldwide have enacted regulations mandating serialization, tracking and tracing of pharmaceutical products down the supply chain during recent years as a response to drug integrity concerns. There are plenty of laws requiring...

eCTD implementation across MENA region: What is the current status?

by Nick | Mar 11, 2021 | Regulatory Affairs

As the electronic Common Technical Document (eCTD) became the standard for submitting Regulatory Information to leading agencies worldwide, its adoption still poses a considerable challenge for those agencies who lack the needed human and/or material resources. How is...

Building Health Literacy: The Value of Good Writing

by Nick | Oct 21, 2020 | Pharmacovigilance, Regulatory Affairs

Scientists, doctors, and health authorities often use written communication to present their research, opinions, or guidelines to the patients. While the questions they approach may be complex, the language should not. In medical documents, misinterpreted information...

CMC: Down the road in effective IND/IMPD writing

by Nick | Oct 8, 2020 | Regulatory Affairs

In the previous two articles, we have shared our experience on various aspects of effective IND/IMPD CMC writing, considering proper planning, assigning a dedicated CMC writing team, and having effective project management. In addition, we discussed technical writing...

Proper Publicizing in CEECs – Path to Successful Social Media Commercials

by Nick | Oct 2, 2020 | Pharmacovigilance, Regulatory Affairs

With the growth of social media network users all over the world, there is no doubt that one of the most accessible and widely used channels for promoting is social media. Statistics show that Facebook and Instagram were used actively with more than 3.4 billion people...

How Mergers and Acquisitions of Pharma Companies affect Regulatory Affairs?

by Nick | Aug 12, 2020 | Regulatory Affairs

It is easy to notice that Mergers and Acquisitions (M&A) have become a frequent occurrence in the Pharmaceutical industry, especially during the previous decades. Pharma industry is one of the leading industries in the number of M&A and the size of investments...

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Drugs serialization and barcoding in Saudi Arabia and MENA region

eCTD implementation across MENA region: What is the current status?

Building Health Literacy: The Value of Good Writing

CMC: Down the road in effective IND/IMPD writing

Proper Publicizing in CEECs – Path to Successful Social Media Commercials

How Mergers and Acquisitions of Pharma Companies affect Regulatory Affairs?

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Drugs serialization and barcoding in Saudi Arabia and MENA region

eCTD implementation across MENA region: What is the current status?

Building Health Literacy: The Value of Good Writing

CMC: Down the road in effective IND/IMPD writing

Proper Publicizing in CEECs – Path to Successful Social Media Commercials

How Mergers and Acquisitions of Pharma Companies affect Regulatory Affairs?

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PV System & QPPV

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