SeerPharma
SeerPharma is a dedicated provider of consulting, training, and software solutions for the pharmaceutical, medical device, and life sciences industries in the Asia-Pacific region. With over 35 years of experience, their mission is to 'Advance Quality and GMP Best Practices in the APAC region.' They offer a comprehensive range of services including GMP compliance advice, training programs, and electronic Quality Management Systems (QMS) implementations, notably MasterControl software modules such as CAPA, Change Control, Document Control, and more. Their goal is to enhance operational efficiency, ensure regulatory compliance, and support industry innovation through tailored solutions, expert guidance, and thought leadership.
Industries
Nr. of Employees
small (1-50)
SeerPharma
Melbourne, Victoria, Australia, Oceania
Services
Advisory services on Quality Management Systems, GMP compliance, facility and equipment reviews, and regulatory strategy across pharmaceuticals, medical devices and life sciences.
Execution of audits (GMP, GDP, GLP/GCLP, IT) and preparation for regulator inspections, including gap analyses and inspection response support.
Classroom and online training courses and customised training programs covering GMP, contamination control, aseptic practice, data integrity and computerized system validation; includes postgraduate programs with academic partners.
Implementation, configuration and validation of cloud-based quality and manufacturing software suites covering document control, training management, CAPA, EBR/eDHR, audit management, risk management, logbooks and equipment maintenance modules.
Provision of contract quality assurance personnel to support validation, documentation, computer system validation and remediation projects.
Advice on meeting requirements from regulators and standards bodies (FDA, TGA, EMA, PIC/S, WHO, ICH), and support for regulatory submissions and inspection responses.
Advisory services on Quality Management Systems, GMP compliance, facility and equipment reviews, and regulatory strategy across pharmaceuticals, medical devices and life sciences.
Execution of audits (GMP, GDP, GLP/GCLP, IT) and preparation for regulator inspections, including gap analyses and inspection response support.
Classroom and online training courses and customised training programs covering GMP, contamination control, aseptic practice, data integrity and computerized system validation; includes postgraduate programs with academic partners.
Implementation, configuration and validation of cloud-based quality and manufacturing software suites covering document control, training management, CAPA, EBR/eDHR, audit management, risk management, logbooks and equipment maintenance modules.
Provision of contract quality assurance personnel to support validation, documentation, computer system validation and remediation projects.
Advice on meeting requirements from regulators and standards bodies (FDA, TGA, EMA, PIC/S, WHO, ICH), and support for regulatory submissions and inspection responses.
Expertise Areas
- Quality and GMP compliance
- eQMS implementation and validation
- Computerised system validation (CSV) and data integrity
- Regulatory inspection readiness and response
Key Technologies
- Electronic Quality Management Systems (eQMS)
- Electronic Batch Records (EBR)
- Electronic Device History Records (eDHR)
- Electronic logbooks
News & Updates
Upcoming webinar hosted by MasterControl, in partnership with SeerPharma, focusing on automating CAPA processes.
An article discussing the latest trends in medical device manufacturing for 2023.
A white paper on FDA guidance regarding cybersecurity in medical devices.
An article on post-market surveillance, adverse event reporting, and recall actions for medical devices.
An article on how SeerPharma assists medical device companies with QMS.
An article on applying ISO 14971 risk management to new medical devices.
Upcoming webinar hosted by MasterControl, in partnership with SeerPharma, focusing on automating CAPA processes.
An article discussing the latest trends in medical device manufacturing for 2023.
A white paper on FDA guidance regarding cybersecurity in medical devices.
An article on post-market surveillance, adverse event reporting, and recall actions for medical devices.
An article on how SeerPharma assists medical device companies with QMS.
An article on applying ISO 14971 risk management to new medical devices.