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.

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 ...
Must-Know Legislation for Medical Device Registration in the EAEU

Must-Know Legislation for Medical Device Registration in the EAEU

EAEU legislation for Medical Device registration has been continuously updating for the last six years since the ...
Strategic Pharmacovigilance Outsourcing Models

Strategic Pharmacovigilance Outsourcing Models

Larger companies often limit their strategic pharmacovigilance activities outsourcing only to highly manual and ...
Medical Device Registration in the Eurasian Economic Union (EAEU)(Part 2)

Medical Device Registration in the Eurasian Economic Union (EAEU)(Part 2)

How do you realize Medical Device Registration in the Eurasian Economic Union (EAEU)? Learn about EAEU Conformity Assessment Routes and MRP.
Advantages of QPPV Outsourcing in the EU/EEA

Advantages of QPPV Outsourcing in the EU/EEA

Advantages of QPPV Outsourcing in the EU/EEA Pharmaceutical companies with a primary base outside the EU, ...
Affiliate Based Outsourcing for Regulatory Affairs

Affiliate Based Outsourcing for Regulatory Affairs

Practical tips on Affiliate Based Outsourcing including for Regulatory Affairsoptimization of local RA setup, management and relevant costs.
7 Reasons To Include Eastern Europe In Your Clinical Trial Strategy

7 Reasons To Include Eastern Europe In Your Clinical Trial Strategy

Choosing the right set of countries, sites and investigators for a clinical trial are critical success factors in ...
Company Registration Requirements in MENA: a Prerequisite for Product Registration

Company Registration Requirements in MENA: a Prerequisite for Product Registration

Company registration is part of the common regulatory requirements in several Middle Eastern and North African ...
Biosimilars in the MENA Region: Regulatory Landscape

Biosimilars in the MENA Region: Regulatory Landscape

Regulatory affairs for biosimilars in Middle East North Africa (MENA) region are evolving as existing guidelines ...

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