Regulatory Insights

Expert guidance on pharmaceutical and medical device regulatory processes, compliance, and best practices

Regulatory Affairs

Understanding the Common Technical Document (CTD)

A comprehensive guide to the CTD structure, its modules, and how to prepare regulatory submissions for marketing authorization in the EU, US, and other ICH regions.

Medical Writing

Writing Clinical Study Reports: ICH E3 Guidelines

Learn the structure and content requirements for Clinical Study Reports according to ICH E3 guidelines, including key sections and regulatory expectations.

Medical Devices

CTD vs MDR: Documentation Requirements Compared

Understanding the differences between pharmaceutical CTD submissions and medical device technical documentation under the EU MDR/IVDR regulations.

Quality Assurance

ISO 14971: Risk Management for Medical Devices

A practical guide to implementing risk management processes for medical devices according to ISO 14971:2019 standards and EU MDR requirements.

Clinical Research

ICH E6(R2): Good Clinical Practice Updates

Key changes in the ICH E6(R2) addendum including risk-based approaches, quality management systems, and implications for clinical trial conduct.

Regulatory Affairs

Preparing the IMPD: Investigational Medicinal Product Dossier

Step-by-step guidance on compiling the IMPD for clinical trial applications, including quality, non-clinical, and clinical sections.

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