5 Articles found
DDi LLC Articles
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Summary of new EU Clinical Trial Regulation
The changes the regulation brings companies need to already be reviewing their current processes, systems and supporting infrastructure for clinical trial applications and operations. They need to do so in every changing regulatory environment where ...
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Regulatory Success Automation
You may think that regulatory automation is something that requires an intense technical infrastructure backed by a big budget to boot. But the truth is, even small businesses can use simple automation tools to improve regulatory success. Companies ...
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Medical Devices: Structured Content Authoring Saves Time & Reduces Cost
Medical device companies creating technical documentation, clinical / post-marketing reports, labeling and quality documentation with increasing regulations and recent MDR/IVDR compliance in mind may find that their traditional approaches to these ...
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Avoiding Regulatory shortfalls in the Submission Path
Commercialization of new drugsrequire careful navigation through complex regulations defined by Global health authorities. Drug development process needs extensive collaborations with internal & external stakeholders, co-ordination with cross ...
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Med Writing: 4 Best Practices for Reusable Global Content
In order to scale, you must reuse content; To reuse content, you must standardize content; To create standardized content, you must develop standards that all content creators adhere to Why Best Practices are needed for Writing for Reuse? Because ...