A multinational manufacturer of cardiovascular devices recently engaged SeerPharma to conduct a comprehensive mock US FDA audit of their operations in Singapore. The audit was conducted against US FDA 21 CFR Part 820 – Quality System Regulation (21 CFR 820). SeerPharma reviewed relevant documentation remotely and then spent three days on-site...
Artificial Intelligence (AI) and emerging technologies are rapidly advancing, influencing every aspect of business operations, including the biotechnology and life sciences sectors.
A decade ago, Duke-NUS Medical School established the Centre of Regulatory Excellence (CoRE) to enhance health products regulatory systems and competency across ASEAN and the broader Asia-Pacific region. CoRE is pivotal in supporting policy innovation and facilitating progress towards effective and efficient health products regulation. As a...
VIMTA is a leading contract research and testing organisation headquartered in India, serving the pharmaceutical, food, and general manufacturing sectors. With over 40 years of experience and a global presence, VIMTA is at the forefront of supporting pharmaceutical companies with their outsourced product development and discovery activities.
SeerPharma consults on 100 to 150 projects every year. Many of these engagements with pharmaceutical and medical device companies involve providing ongoing support for business needs related to Quality Assurance (QA) and Good Manufacturing Practice (GMP) compliance. Our clients continue to rely on our expertise for regular remote and on-site...
The International Society for Pharmaceutical Engineering (ISPE) is a global nonprofit organisation dedicated to advancing scientific, technical, and regulatory progress across the entire pharmaceutical lifecycle. With a widespread presence, ISPE operates through individual chapters and affiliate organisations to effectively support professionals...
SeerPharma is proud to announce the continued success of our partnership with the University of Technology Sydney (UTS) in offering globally recognised postgraduate qualifications in Good Manufacturing Practice (GMP).
SeerPharma has been a strategic partner of MasterControl, a market-leading software provider, for the past eight years in the APAC region. During this time, we have assisted nearly 100 pharmaceutical and medical device companies in automating their quality management and manufacturing workflows. This level of automation has enabled our clients to...
When managing Quality/GMP, individuals in companies gain knowledge through formal training and on-the-job experience. Knowledge gained can be considered through 4 stages of learning:
ISPE Pharma 4.0TM – is a trademark owned by the International Society for Pharmaceutical Engineering, Inc. and registered in multiple countries.
The International Society for Pharmaceutical Engineering (ISPE) is a global not-for-profit association dedicated to serving its members across the entire pharmaceutical product lifecycle. With affiliates...
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