Cynata Therapeutics Limited is an Australian stem cell and regenerative medicine company that is developing a therapeutic stem cell platform technology, Cymerus™.
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Vaxxas is a Brisbane based Medical Device Company pioneering a next-generation vaccine delivery platform that enables robust immune system activation by targeting vaccine components to the abundant immunological cells immediately below the surface of the skin.
Malaysian Organisation of Pharmaceutical Industries (MOPI) was incorporated in 1981. The members consists of all manufacturers of pharmaceutical products whose manufacturing facilities are located in Malaysia and are licensed by the Drug Control Authority, Ministry of Health, Malaysia.
SeerPharma was asked to provide validation management and execution support for an established Active Pharmaceutical Ingredient (API) production facility in Australia.
After reviewing the market with a project to replace their existing GMP induction and refresher training program, a leading Australian natural health care brand has recognised the value of SeerPharma’s online GMP training solution.
Zuellig Pharma is Asia’s leading healthcare service provider offering a broad range of innovative services including distribution of pharmaceuticals, medical devices, special solutions and other healthcare related consumer products.
As a Pharmaceutical company, you are required to investigate the cause of quality failures or production problems. Surprisingly though, “Failure to thoroughly investigate…” is a common finding from regulatory inspections in the PIC/S, TGA and FDA GMP environment.
SeerPharma has assisted an Australian 3D Printing Medical Device company to develop an ISO 13485 compliant Quality Management System (QMS).
As a Medical Device company, you are required to investigate the cause of quality failures or production problems. Surprisingly though, “Failure to thoroughly investigate…” is a common finding from quality (management) system inspections and audits against FDA 21 CFR Part 820 and ISO 13485.
An Australian pharmaceutical company engaged SeerPharma to prepare them for a TGA and FDA GMP inspection. Their Engineers were relatively inexperienced in dealing with regulatory inspections and the company required them to gain experience quickly in preparation for the FDA’s arrival. SeerPharma were requested to perform a mock audit to help meet...
