Pharmalytics is Australia’s newest GMP contract analytical testing service provider for the pharmaceutical, life science, clinical trial and veterinary industries. However, in many tiny ways we’re unlike any lab that’s come before us. We were established by some of the industry’s foremost thinkers and pioneers. Our team has unparalleled experience in pharmaceutical analysis, quality assurance and regulatory affairs. And we are the only contract pharmaceutical testing facility in the country with full electronic data integrity and quality management systems. If you are looking for a partner to support your existing products, or new formulations and dosage forms, and if you have zero tolerance for aging equipment, redundant processes or human error of any kind, contact us. The many tiny differences that make Pharmalytics unique could make a world of difference to you, to your company, and your bottom line.
Pharmalytics partners with an Industry leading TGA licenced microbiological laboratory. All samples are fully validated and include full electronic reporting. Whatever testing you have performed by Pharmalytics – in our lead lab or at our Microbiological lab site – is combined into a single, comprehensive report.
Can’t find the service you’re looking for? Please get in touch. We’re adding to our capabilities regularly.
With state-of-the-art facilities, equipment and techniques, Pharmalytics incorporates industry best practice at all times. With full audit trails, electronic signatures, and an integrated electronic quality management system, you can be assured your analytical results and data are safe and secure.
US FDA FEI: 3016044111
Pharmalytics employ a full 21 CFR Part 11 electronic quality and documentation system. Every single thing we do is electronic. And we’re the only pharmaceutical contract testing laboratory in the country that operates to this standard. Put simply, we have removed manual recording, redundant processes and human error from the equation. All electronic records are database driven, locked, secured and cannot be altered – and each analysis, performed by a method, can only be recorded by trained and qualified analyst for your samples.
Pharmalytics is a first-to-market partner for Agilent Technologies and Mettler Toledo.
Agilent Technologies is a global leader in the supply of instruments, services and consumables for the life sciences, diagnostics and applied chemical markets. Their end-to-end portfolio enables reliable, precise answers for all stages of a product’s lifecycle and ensures excellence, optimal performance and robustness for Pharmalytics at all times.
Mettler Toledo precision instruments are renowned in laboratories all over the world for the accuracy of their results. Thanks to their partnership, Pharmalytics can reliably deliver innovations in performance, measurement techniques and evaluation procedures to analyze contents, concentrations, material properties and compositions. Our Mettler Toledo instruments, combined with LabX software, fully support the current requirements of regulatory bodies including the TGA and FDA under a 21CFR Part 11 compliant framework.
Just 40 minutes from Melbourne’s airport and CBD, the Pharmalytics lab offers the latest
Employing data systems validated to 21 CFR Part 11 requirements, every stage of the Pharmalytics process is fully electronic.
As well as introducing a level of GMP compliance that has never been available in a contract GMP laboratory In Australia before, this means we can offer an unparalleled level of consistency when customising your analytical requirements.
An analytical chemist by profession, Carmen has built a strong understanding of laboratory testing procedures and exceeded GMP guidelines for many years. She has extensive experience in quality management in GMP and FDA compliant laboratories.
Carmen is responsible for ensuring that Pharmalytics holds itself to the highest standards and continues to outperform the industry. Carmen and her young family are keen karate enthusiasts. She’s the perfect person to keep our team in line.
Tameka is highly respected in the fields of GMP compliance, quality systems, pharmaceutical testing, method development and microbiology testing. She has developed and validated hundreds of chromatographic methods to GMP guidelines, and has been instrumental in the growth of a number of leading companies through the introduction of various testing techniques, quality systems and procedures. Tameka has maintained an excellent GMP audit record and continues to hold herself and Pharmalytics to the highest of standards. With a Bachelor of Computer Science, plus bachelor degrees In Forensic science (Honours) and Science (Biotechnology), no one could be better qualified to leads our team of analysts and advance our leadership through electronic quality systems.