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
Case Study: International & Local Pharmacovigilance/Medical Information Services Urgent Action
Marketing Pharmaceutical Products in CIS/EAEU
Explore regulatory differences from the EU, recent legislative changes, and practical RA & PV considerations.
PV & MI Outsourcing Benefits for Biotech
Learn how PV/MI outsourcing enables biotechs to reduce costs, scale efficiently, strengthen compliance, and accelerate market readiness.
Topic
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
Whitepaper
Regulatory Affairs Outsourcing
Affiliate-Based Outsourcing for Regulatory Affairs acts as an addition ...
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?
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
Webinar: Different Affiliate-Based Outsourcing Models for Regulatory Affairs
Often questions arise about the ...
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
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 EAEU: Learn about pathways for market authorization, the CTD format, and approvals in the Eurasian Economic Union.
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
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?
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 from Scratch
In the EU/EEA, US, and other major pharmaceutical markets, you ...
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
EAEU legislation for Medical Device registration has been continuously updating for the last six years since the ...
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)
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
Pharmaceutical companies with a primary base outside the EU, ...
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
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 is part of the common regulatory requirements in several Middle Eastern and North African ...
