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
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
Discover how clinical research and medical writing intertwine across all phases of drug development, from drafting early trial documents to post-marketing activities.
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.
Topic
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 ...
Biosimilars in the MENA Region: Regulatory Landscape
Regulatory affairs for biosimilars in Middle East North Africa (MENA) region are evolving as existing guidelines ...
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
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
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
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
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
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?
This article reviews Clinical Study Start-up Differences Between West & East Europe, timelines, and processes. ...
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
eCTD Submission Strategies, including outsourcing, are influenced by varying requirements in various regions ...
