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

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.

How does the conflict between UA & RU impact the pharma industry?

How does the conflict between UA & RU impact the pharma industry?

Like the rest of the world, the pharmaceutical and biotech industries are beginning to worry about their ability ...
How does the Russian invasion impact the pharmaceutical industry?

How does the Russian invasion impact the pharmaceutical industry?

Like the rest of the world, the pharmaceutical and biotech industries are beginning to worry about their ability ...
How To Manage An Early Phase Oncology Study: Project Manager Insights

How To Manage An Early Phase Oncology Study: Project Manager Insights

Clinical development of oncology drugs has one of the lowest success rates of the development of Investigational ...
How To Improve Patient Recruitment In Early Phase Oncology Trials

How To Improve Patient Recruitment In Early Phase Oncology Trials

The difficulties of recruiting in clinical trials, and particularly cancer patients in their early stages, can ...
What are the advantages of a hospital-based Early Phase Unit?

What are the advantages of a hospital-based Early Phase Unit?

Choosing the right setting for your early phase trial can be challenging. As a sponsor, it's natural to remain ...
Smooth Switch to the EAEU Marketing Authorization for Medicinal Products

Smooth Switch to the EAEU Marketing Authorization for Medicinal Products

Webinar: Smooth Switch to the EAEU Marketing Authorization for Medicinal Products The webinar will highlight the ...
Finalization of the European Database on Medical Devices (Eudamed) Regulation Implementation

Finalization of the European Database on Medical Devices (Eudamed) Regulation Implementation

There is an increased demand for Materiovigilance solutions in recent years as the usage of medical devices keeps ...
What are the Challenges of Decentralized Clinical Trials?

What are the Challenges of Decentralized Clinical Trials?

The COVID-19 pandemic has accelerated the adoption of decentralized clinical trials by emphasizing the tangible ...
Affiliate Based Outsourcing

Affiliate Based Outsourcing

Whitepaper Regulatory Affairs Outsourcing Affiliate-Based Outsourcing for Regulatory Affairs acts as an addition ...
Challenges In Early Phase Oncology Trials

Challenges In Early Phase Oncology Trials

Cancer is the biggest cause of mortality globally, with 19.3 million new cases and over 10 million deaths expected ...
What is the Clinical Trials Regulation?

What is the Clinical Trials Regulation?

The EU CTR is the new Regulation that govers all interventional clinical trials using human medicinal products. By ...
Different Affiliate Based Outsourcing Models for Regulatory Affairs

Different Affiliate Based Outsourcing Models for Regulatory Affairs

Webinar: Different Affiliate-Based Outsourcing Models for Regulatory Affairs Often questions arise about the ...
What is Medical information and Communication?

What is Medical information and Communication?

It is no secret that the evolution of evidence-based medicine and shared decision-making, and novel technologies ...
Preparing for Affiliate-Based Outsourcing for Regulatory Affairs

Preparing for Affiliate-Based Outsourcing for Regulatory Affairs

Affiliate-Based Outsourcing (ABO) model for regulatory affairs works as a replacement or an extension of the ...
Drug Registration in the Eurasian Economic Union (EAEU)

Drug Registration in the Eurasian Economic Union (EAEU)

Drug registration in the EAEU: Learn about pathways for market authorization, the CTD format, and approvals in the Eurasian Economic Union.
Marketing Authorization Renewal in the MENA Region

Marketing Authorization Renewal in the MENA Region

Regulatory Authorities across the MENA region indicate a specific validity period for the Marketing Authorization ...
How to register a Medical Device in the EAEU

How to register a Medical Device in the EAEU

Since the establishment of the Eurasian Economic Union in 2015, a significant change is quickly coming into life: ...
How to prepare for Affiliate-Based Outsourcing for Regulatory Affairs?

How to prepare for Affiliate-Based Outsourcing for Regulatory Affairs?

Webinar: How to prepare for Affiliate-Based Outsourcing for Regulatory Affairs? Affiliate-Based Outsourcing (ABO) ...
Setting Up A Pharmacovigilance System

Setting Up A Pharmacovigilance System

Setting Up a Pharmacovigilance System from Scratch In the EU/EEA, US, and other major pharmaceutical markets, you ...
Centralized Procedure in the GCC Region

Centralized Procedure in the GCC Region

The Centralized Procedure in the GCC Region describes the possibility to register pharmaceutical products ...

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