For more than 35 years, SeerPharma has been a trusted partner to pharmaceutical and medical device organisations across the Asia-Pacific (APAC) region, providing expert guidance on Quality Management Systems (QMS) and Good Manufacturing Practice (GMP) compliance.
At the heart of our work lies a team of highly experienced quality and regulatory...
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...
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.
SeerPharma has a long-standing reputation for helping pharmaceutical and medical device companies establish new or upgrade existing GMP manufacturing facilities. The team is currently engaged in multiple facility projects across the APAC region, working on complex facility projects involving the manufacture of:
For most medical device manufacturers, the roadmap to market will start with ISO 13485:2016 certification. Obtaining an ISO 13485:2016 certificate is evidence that the Quality Management System in place is compliant with international standards and is a key component of a registration package with the regulators.
This article was originally published by SeerPharma's business partner MasterControl and is republished in-part here with their permission.
Research and operations of Medical Technology, Biotechnology and Pharmaceutical (MTP) companies aligned with and in some cases certified to Quality Management System (QMS) Standards will ensure Australia is at the forefront of medical innovation.
MTPConnect is a not-for-profit organisation, established by the Australian Federal Government’s Industry Growth Initiative. MTPConnect’s aim is to accelerate the rate of growth of the medical technologies, biotechnologies and pharmaceuticals (MTP) sector to increase commercialisation, collaboration and establish Australia as an Asia-Pacific hub...
“Our goal is to determine if the firm’s manufacturing operations are in a state of control. The CGMPs are a management-based regulatory approach. We do not specify how a company must structure its quality system. The regulations provide general expectations and we let the firm’s management structure its GMP compliance program accordingly. A GMP...
The Corrective and Preventative Action (CAPA) system is central to every Quality Management System (QMS). Quality professionals know the importance of managing CAPAs when a quality event occurs.
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