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Insights & Resources
For Life Sciences Professionals.

Whether you’re a healthcare professional, a researcher, or simply interested in drug development, you’ll find valuable information and resources here that can help you stay informed and make informed decisions. Let us know what else you’d like to hear about!

Featured Insights

How Mid-Sized CROs and Site Networks Deliver Clinical Trial Success

The Perfect Match: How Mid-Sized CRO–Site Network Partnerships Drive Clinical Trial Success – Watch the Recording

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How medical writing supports every stage of the drug’s lifecycle

How medical writing supports every stage of the drug’s lifecycle

Discover how clinical research and medical writing intertwine across all phases of drug development, from drafting early trial documents to post-marketing activities.

Blog Unlock Trial Success with the FSP Hybrid Model

Harmonizing Product Information Across Baltic Markets

In this case study, we share how one of our partner companies successfully harmonized their SmPC, PIL, and labelling across the Baltic region, working with our medical writing experts.

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Successful Medical Device Registration in EAEU: New Legislation (Part 1)

Successful Medical Device Registration in EAEU: New Legislation (Part 1)

Webinar: Successful Medical Device Registration in EAEU: New Legislation (Part 1) The webinar discusses and ...
Saudi FDA’s New Pricing Guidelines and Impact on the Region

Saudi FDA’s New Pricing Guidelines and Impact on the Region

In a highly evolving regional pricing environment, Saudi Arabia (KSA) is no exception. The Saudi Food and Drug Authority (SFDA) has been periodically reviewing its pricing mechanisms and criteria so that the country becomes a regional reference for the prices of pharmaceutical products. What followed is a change in the pricing strategy by SFDA and a shift from price takers to price makers.
Marketing pharmaceutical products in CIS countries / Eurasion Union

Marketing pharmaceutical products in CIS countries / Eurasion Union

The interest of pharmaceutical companies in expanding business across CIS region has been constantly growing. For ...
Webinar: Regulatory Strategy in the EAEU and Rest of CIS Countries

Webinar: Regulatory Strategy in the EAEU and Rest of CIS Countries

Regulatory strategy in EAEU and CIS regions differ from other regions as market access to these countries can be a ...
CMC: Effective Writing Of IND And IMPD

CMC: Effective Writing Of IND And IMPD

This artical focuses on best practices in delivering an effective CMC writing strategy when writing an IND or IMPD.
Webinar: Effective IMPD Writing. The Quality Part

Webinar: Effective IMPD Writing. The Quality Part

Effective IMPD writing, including the quality part is a vital document that contains information about an ...
Clinical Study Start-Up: Is there any Difference Between Western and Eastern Europe?

Clinical Study Start-Up: Is there any Difference Between Western and Eastern Europe?

This article reviews Clinical Study Start-up Differences Between West & East Europe, timelines, and processes. ...
Expediting access through Reliance Pathways: MENA region

Expediting access through Reliance Pathways: MENA region

Reliance models are review pathways used by Regulators to expedite the patient access to essential pharmaceutical products and to overcome resource constraints and priorities. Recently, several National Competent Authorities (NCA) in the Middle East North Africa (MENA) region have implemented the Abridged and Verification reviews. These regulatory procedures allow the approvement of needed innovative and/or life-saving drugs.
Webinar: eCTD Submission Strategies. In-house vs. Outsourcing

Webinar: eCTD Submission Strategies. In-house vs. Outsourcing

eCTD Submission Strategies, including outsourcing, are influenced by varying requirements in various regions ...
3 Factors Affecting the Successful Collection of Drug Safety Information in Social Networking Sites

3 Factors Affecting the Successful Collection of Drug Safety Information in Social Networking Sites

Health information that has been posted online by patients can efficiently supplement your post-marketing drug ...
Drugs serialization and barcoding in Saudi Arabia and MENA region

Drugs serialization and barcoding in Saudi Arabia and MENA region

  An increasing number of countries worldwide have enacted regulations mandating serialization, tracking ...
eCTD implementation across MENA region: What is the current status?

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

As the electronic Common Technical Document (eCTD) became the standard for submitting Regulatory Information to ...
Building Health Literacy: The Value of Good Writing

Building Health Literacy: The Value of Good Writing

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 may endanger the health and life of a patient. Thus, the main goal in medical writing is to convey the message clearly and concisely to avoid misinterpretation.
CMC: Down the road in effective IND/IMPD writing

CMC: Down the road in effective IND/IMPD writing

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 particulars giving some key messages on document preparation. Now, we will discuss other important points. These are safety, data completeness, and geographical regions.
Proper Publicizing in CEECs – Path to Successful Social Media Commercials

Proper Publicizing in CEECs – Path to Successful Social Media Commercials

With the growth of social media network users all over the world, there is no doubt that one of the most widely used channels for promoting is social media. Statistics show that Facebook and Instagram were used actively with more than 3.4 billion people daily by January 2020. Therefore, since medical devices and over-the-counter medicines are being more often promoted by commercials on social media nowadays, there is a greater risk of hidden or misleading advertisements.
How Mergers and Acquisitions of Pharma Companies affect Regulatory Affairs?

How Mergers and Acquisitions of Pharma Companies affect 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 for such transitions. The value for M&A in the pharmaceutical sector was $221 billion in the first half of the year 2015. In 2019, the worth of pharma companies M&A activities have reached $357 billion.
CMC: Best Practice in Effective IND and IMPD writing

CMC: Best Practice in Effective IND and IMPD writing

This time we will focus on technical writing and preparation for it. Also, I will provide some primary recommendations for CMC writers. The IND/IMPD being a regulatory document, has the same structure as CTD dossier. However, it includes remarkably less information on the developmental product, yet, the technical writers should understand that they will need to prepare the document in the way to reflect the actual production process and control further during the development in the later clinical phases.
What do you need to know while preparing RMP for EAEU and CIS region?

What do you need to know while preparing RMP for EAEU and CIS region?

Preparation of Risk Management Plan (RMP) for a specific medicinal product usually is the responsibility of the Qualified Person Responsible for Pharmacovigilance (QPPV) and its team. Thus, QPPVs and their team's should be familiar with legislation requirements for RMP preparation in different regions. Within this article, we will concentrate on the Eurasian Economic Union (EAEU) and identify specific conditions of EAEU countries as well as to try to understand the expectations of Competent Authorities in this region.
CMC: Effective Writing of IND and IMPD

CMC: Effective Writing of IND and IMPD

Do we truly know how to ensure IND or IMPD Quality (CMC) part is written in good quality, consistent and clear technical language? How to effectively manage the writing process? In this article, I will focus on these questions and the initial IND/IMPD, required to start clinical investigations in humans. Furthermore, I will provide the key features and practical advice on how to deliver effectiveness. Firstly, we have to define the team in order to understand if the organization has capabilities to do CMC writing in-house or needs to outsource.
Running a Clinical Trial in Ukraine

Running a Clinical Trial in Ukraine

Despite the fact that Ukraine is the largest country in Eastern Europe with a large population of treatment-naïve patients, well organized public health care sector and significant number of medical sites accredited for clinical trial conduction, country has utilized only 15% of its current potential for hosting clinical trials. During 2017, the European Medicine Agency (EMA) gave positive recommendations on 94 new drug applications and 49 of them were tested in clinical trials in Ukraine. During the same year, the US FDA approved 151 new drugs, and 28 of them were also studied in Ukraine.

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