For more than 35 years, SeerPharma has partnered with organisations involved in the supply, manufacture, and distribution of Medical Devices and In Vitro Diagnostics (IVDs) across the Asia-Pacific region.
Our team supports companies that design, develop, and manufacture medical devices and IVDs across of all classifications, helping ensure their...
Life sciences organisations work across diverse countries, languages, and regulations, where accurate communication is vital for compliance and safety. Traditional translation methods are slow and error-prone, creating barriers to global alignment. MasterControl’s AI-powered eQMS removes these challenges by enabling instant translation, clear...
Entering the medical device industry is an exciting venture—but it comes with a maze of regulatory requirements that can feel overwhelming, especially for startups and new manufacturers. One acronym you’ll encounter early and often is MDSAP: the Medical Device Single Audit Program.
Across the pharmaceutical, biopharmaceutical and medical device industries, process validation has historically been structured around the trilogy:
The PDA Aseptic Manufacturing Excellence Conference 2025 (13–14 October, Melbourne) will be a premier gathering for professionals shaping the future of aseptic manufacturing. The event will bring together regulators, industry leaders, and innovators to explore how organisations can align with evolving international standards while adopting new...
The Master of Good Manufacturing Practice from the University of Technology Sydney is your pathway to an industry-recognised qualification, whether you’re launching your career or stepping into a more senior role.
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...
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