A multinational pharmaceutical contract manufacturer recently required the assistance of a senior pharmaceutical QA resource to assist with managing Quality and GMP issues at their manufacturing site.
Cell therapies are an emerging form of healthcare that have started to produce transformative outcomes for patients with previously refractory diseases, but they are substantially more complex than small molecule or biologic drugs and present significant challenges for researchers and companies in cell therapy translation.
SeerPharma’s Software Solutions team has been engaged to implement an electronic Quality Management System (eQMS) for a major multinational pharmaceutical company.
As part of our commitment to the local biotech sector, SeerPharma was proud to sponsor a BioMelbourne Network session on Corporate Culture and Risk earlier this year.
SeerPharma was asked to conduct a mock GMP audit of a Korean Pharmaceutical company that produces non-sterile solid dosage forms and finished products.
A number of firms have requested our expertise to provide technical and compliance audits of contract manufacturers that they currently use in Europe and Asia.
A major pharmaceutical distribution organisation engaged the services of SeerPharma (Singapore) Pte Ltd to provide a review on the compliance of its core SAP-Centric solution to the GxP Computer Systems Validation (CSV) requirements of both FDA 21 CFR Part 11 and PIC/S Guide to GMP Annex 11. There were 2 phases to this project.
A biopharmaceutical manufacturer engaged SeerPharma to provide on-going coaching to their Quality personnel and advise on improvements to help prepare for a FDA inspection.
Auspman (Western Australia Hospitals Central Pharmaceutical Manufacturing Facility) is a TGA-licensed contract manufacturer of non-commercial pharmaceuticals for hospitals, located within the Pharmacy department of Princess Margaret Hospital in Subiaco, WA.
SeerPharma’s inaugural Symposium was a great success with Operational and Quality Directors from over 30 Pharmaceutical and Medical Device / Medical Technology companies such as CSL, Patheon, Alere Medical and MSD in the crowd.