With the ever-evolving advancements of computerised systems and their involvements in the pharmaceutical, medical device, biotechnology and clinical trial industries, it is more critical than ever to ensure that these systems are appropriately assessed, validated and controlled. This is essential to safeguard the ensuing data integrity, product...
Artificial Intelligence (AI) is reshaping industries worldwide, and life sciences is no exception. From drug discovery to clinical decision support, AI has the potential to transform the development, testing, and delivery of therapies. Yet, while the promise is immense, adoption remains cautious. The road ahead requires striking a balance between...
Duke-NUS Medical School established the Centre of Regulatory Excellence (CoRE) over a decade ago to strengthen health product regulatory systems and capabilities across ASEAN and the wider Asia-Pacific region.
The pharmaceutical industry is experiencing rapid advances in biologics, with biopharmaceuticals delivering novel, targeted treatments that are transforming patient care. Across the Asia-Pacific region, leading organisations such as CSL, Pfizer, Biocon, Samsung Biologics, ThermoFisher, and WuXi, along with numerous small to medium-sized...
For over 35 years, SeerPharma has been at the forefront of advancing Quality and GMP best practices within the pharmaceutical and medical device sectors. Our clients span the full product lifecycle—from early-stage clinical trials through to international market distribution.
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The latest revision of ICH E6 (R3), finalised in January 2025 and enforced in Europe since 23 July 2025, marks a significant shift in clinical trial governance, moving beyond incremental updates to reflect modern trial practices and technologies. The guideline emphasises quality by design, risk-based proportionality, and clearer delineation of...
Recurring deviations—especially those involving the same or similar issues—are often red flags for regulatory inspectors. In many cases, significant inspection deficiencies related to inadequate corrective actions could have been prevented if the organisation had recognised the patterns earlier and taken proactive steps.
In industries where compliance is critical such as pharma, biotech, and medical devices, the way we train our workforce has real-world consequences. It affects not just audit outcomes, but also operational safety, product integrity, and ultimately, patient wellbeing.
Data Integrity failures remain one of the most common reasons for regulatory action in the pharmaceutical industry and continue to be among the most frequently cited findings in inspections globally. Notably, approximately 60% of these failures could be avoided with the implementation of robust data governance frameworks.
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