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White Papers & GLOBAL Guides

Designed to be educational, our white papers take a deep dive into important regulatory topics and our GLOBAL Guides provide readers with an overview of regulatory topics and industry resources. 

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GLOBAL Guide

 

Clinical Trials Information System (CTIS) requires sponsors to provide both a protocol synopsis and a lay summary of the study's results. Here are some tips for success.

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White Paper

Inspection happens. This white paper provides some guidance on how to be ready with purposeful documentation and planning. The authors also provide tips on creating an Action, Decision, and Issues (ADI) and how to storyboard for success.

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White Paper

The CRO with a Proven Track Record in Medical Device and In-Vitro Diagnostic (IVD) Regulatory Consulting and Writing Services

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White Paper

This white paper provides details on the impact COVID-19 has had on the implementation of the Medical Device Regulation (MDR), implications for medical device companies, and actionable steps companies can take to use this delay to position them for success.

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White Paper

Have a new in vitro diagnostic seeking approval? Transitioning a legacy device from compliance under IVDD to compliance under IVDR? Check out our tips and tricks for starting the performance evaluation process under EU Regulation 2017/746 (IVDR).

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