Meet the Expert: Lucy Radley
Our “Meet the Expert” series introduces you to our team of experts around the world. This “behind the curtain” view will help you get to know who we are on a professional and personal level, and...
From Idea to Market: The Five Stages of Product Development
The exact product development process for medical devices differs from region to region, with different regulatory expectations that need to be met in the EU, USA, UK and other regions. These precise...
Meet the Expert: Renata Pankiewicz
Our “Meet the Expert” series introduces you to our team of experts around the world. This “behind the curtain” view will help you get to know who we are on a professional and personal level, and...
Clinical Research Solutions
FDA Publishes Complex Generics News Resource
Today the FDA is publishing a new web page to share the most recent FDA actions and activities related to complex generics. This new resource is part of FDA’s continued commitment to ensuring...
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EMA Good clinical practice (GCP) inspection procedures
The Good Clinical Practice (GCP) Inspectors Working Group has developed procedures for the coordination, preparation, conduct and reporting of GCP inspections requested by the European Medicines...
FDA publishes MAPP 5223.6, Assessment of the User Interface of a Drug-Device Combination Product Submitted in a Pre-ANDA Communication or an ANDA
Today, FDA published a new Manual of Policies and Procedures (MAPP), “Assessment of the User Interface of a Drug-Device Combination Product Submitted in a Pre-ANDA Communication or an ANDA (5223.6).”...
How to Sustain Compliance with EU MDR (2017/745) After the Deadline
The Medical Devices industry breathed a sigh of relief for the new European Medical Device Regulation (EU MDR), but the May 2021 deadline is now right around the corner. The transition from the...
Clinical Research Solutions
The Evolution of Medical Writing
Medical writers must not only have solid writing skills, but knowledge in the context and terminology of medical topics. At times, they may even need to analyze the logic of a passage. Examples of...
Do You Need a Resource Management Team?
In the latest PMI report Pulse of the Profession 2020 (2020), 11.4% of surveyed organizations attribute investment waste to poor project performance. What defines project performance and ultimately...
5 of the Most Common Biopharma Risks Today
Spending on prescription drugs in the United States is expected to reach $600 billion by 2023. The continuously increasing need for pharmaceuticals is mostly driven by an aging population, a rise in...
Clinical Research Solutions
A Guide to Clear-Cut Planning and Program Execution
The landscape of clinical trials and other clinical development projects has dramatically changed in recent years. Progress made in scientific discovery is paving the way to novel therapies and...
7 Medical Writing Tips for the Oncology Field
In the wake of the 21st Century Cures Act (December 2016), the FDA has switched gears to accelerate the development of novel therapies and speed up the review process, particularly in the field of...
Medical Writing Lean Overview
When applied rigorously and comprehensively, lean principles can reduce organizational costs while increasing productivity and strengthening the overall quality of submissions What is “Lean” as it...
The Importance of Pharmacovigilance for Labs
Adverse drug reactions (ADRs) are a significant cause of deaths and emergency hospital visits. The good news is that monitoring and understanding ADRs can help minimize and even prevent such events...