Expert guidance on pharmaceutical and medical device regulatory processes, compliance, and best practices
Comprehensive guide to medical device safety requirements, post-market surveillance, vigilance systems, and risk management under MDR/IVDR regulations.
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Expert guidance on safety data management, signal detection, case processing, and regulatory reporting for effective pharmacovigilance systems.
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Best practices for implementing robust PMS systems, data collection strategies, signal detection, and regulatory compliance for both pharmaceuticals and medical devices.
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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.
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Learn the structure and content requirements for Clinical Study Reports according to ICH E3 guidelines, including key sections and regulatory expectations.
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Understanding the differences between pharmaceutical CTD submissions and medical device technical documentation under the EU MDR/IVDR regulations.
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A practical guide to implementing risk management processes for medical devices according to ISO 14971:2019 standards and EU MDR requirements.
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Key changes in the ICH E6(R2) addendum including risk-based approaches, quality management systems, and implications for clinical trial conduct.
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Step-by-step guidance on compiling the IMPD for clinical trial applications, including quality, non-clinical, and clinical sections.
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