Pacific Life Sciences Pty Ltd
- Australia & New Zealand
- Human Medicines, Biopharmaceuticals
- Service category
- Quality management services, Regulatory services - CMC writing - medical writing, …
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We believe that PLS offers a rare combination of skills, directly resulting from our current, broad experience in the functional food, healthcare, pharma and related industries.
Internal ongoing high-level training one of our commitments and we commit a high proportion of our income to training and technical capabilities.
As a summary, we offer consultancy services in the following fields :
Good Manufacturing Practice [GMP+] – advice, training, system implementation – solutions to suit the application (see below for more);
Quality Management Systems – advice, training, system setup and implementation – solutions to suit the application;
Product Regulatory Affairs – dossier preparation, submissions, FSANZ compliance, TGA eBS interface;
Facility Regulatory Affairs – related to 1 and 2 above, getting facilities ‘regulator-ready’, or compliant to Food Safety requirements;
Product Concept Assistance – biochemistry, pharmacology & toxicology research and advice;
Product Design – formulation advice, trials management, safety & efficacy assessments;
Facility Concept Design – taking client requirements through to concept designs including CAD.
+ Assistance with all aspects of GMP can be provided. These include documentation, audit preparation, systems analysis, data handling, stability testing management, continuous product quality review, quality risk management, process analysis, electronic data monitoring, qualification and validation, specifications and testing management, materials handling, contamination control and more……
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