biopharmaceutical

Understanding the Impact of the Updated Schedule M on Pharmaceutical Manufacturing Standards

Posted by: Saurangi Shah June 28, 2024

Short Description In an effort to bring the na

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Regulation/Guidelines

Cosmetic Label Compliance India : A Guide to Compliance

Introduction Looking for Cosmetic Label Compliance India? Are you a cosmetic manufacturer or importer navigating the complex world of Indian regulations? Ensuring your product labels comply with the latest cosmetic...

26th March, 2025

Regulation/Guidelines

Clinical Investigation Approvals: An Overview of Forms MD-22 and MD-23

Summary As per MDR 2017, “clinical investigation” means the systematic study of an investigational medical device in or on human participants to assess its safety, performance or effectiveness. Clinical investigations...

15th January, 2025

Regulation/Guidelines

Regulatory Challenges of SaMD: Navigating Global Standards and Compliance

Overview Navigating Software as a Medical Device regulation involves addressing varying global standards, including risk-based classifications. Challenges include managing risks, demonstrating clinical evidence, and ensuring data security. Harmonisation efforts and...

4th November, 2024

Regulation/Guidelines

The Future of SaMD: Emerging Trends and Innovations

Overview The future of (SaMD) Software as a Medical Device will see breakthroughs in Artificial Intelligence-based diagnostics, personalised treatments, and remote monitoring. Emerging trends emphasise real-time data integration, stronger regulatory...