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About Pharmalytics

Pharmalytics is Australia’s newest GMP contract analytical testing service provider for the pharmaceutical, life science, clinical trial and veterinary industries. With state-of-the-art technology and techniques, and no tolerance for aging equipment, redundant processes or human error of any kind, the tiny differences between Pharmalytics and our competitors will make a world of difference to you, to your company, and your bottom line.

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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.

Medicinal
Cannabis &
Cannabinoids
  • Cannabis flower testing to TGO93 requirements
  • TGO93 – complete suite of testing conducted In-house on validated methods including Aflatoxins, Ochratoxin A, Heavy Metals and Pesticides to Ph Eur 2.8.13
  • Intermediate CBD and THC resin testing
  • Determination of full spectrum CBD products
  • Finished product assays in oils and capsules
  • Comprehensive Terpene profiles
  • Complete Cannabinoid profiles
  • Stability Studies to ICH guidelines
ICH stability
storage & testing
  • Validated stability chambers to ICH guidelines
  • Electronically controlled with 24/7 environmental monitoring
  • Storage, coordination & mgmnt of stability samples
  • Design and validation of your stability programs
  • Permanent stability conditions:
    • 2-8 °C
    • 25 °C / 60 % RH
    • 30 °C / 65 % RH
    • 30 °C / 75 % RH
    • 40 °C / 75 % RH
  • Flexible and short-term alternate stability conditions
  • Photostability trials
  • Transportation and freeze / thaw studies
Microbiological testing

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.

Method
development &
validation
  • Methods developed to meet your requirements
  • Validation to ICH guidelines
  • Forced degradation / stability indicating vaildations
  • Verification of pharmacopeial methods
  • Analytical transfer of existing methods into our quality system
  • Extractable / Leachable studies – design and testing
  • Cleaning validations
Research &
development
  • Assay and related substance testing in a single HPLC analysis
  • Development of specialist and one-off assays
  • Product contamination Investigations
  • Impurity Identifications
  • Partnering with you to address your unique challenges
Pharmacopeial Testing
  • Current BP, EP and USP monographs
  • Raw material and finished product testing
  • Identification by FTIR and wet chemistry techniques
  • Water content, LOD, Ash
  • Residual Solvents
  • Assay by HPLC and GC techniques
  • Dissolution and Disintegration
  • Physical testing
  • Microbiological – sterile and non-sterile

 

Can’t find the service you’re looking for? Please get in touch. We’re adding to our capabilities regularly.

Full accreditation

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.

TGA Licence:
MI-2019-LI-09504-1

APVMA Licence No:
6224

US FDA FEI: 3016044111

Fully electronic quality systems

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.

Leading Partners

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.

Newest laboratory

Just 40 minutes from Melbourne’s airport and CBD, the Pharmalytics lab offers the latest

  • HPLC and uHPLC systems with DAD, UV, RI and ELSD detectors
  • LC – GPC/SEC
  • GC systems with split/splitless and multimode inlets, FID and headspace samplers
  • GC-MSD single quadrupole mass spectrometer with extraction source and chemical ionisation
  • GC – Triple Quadrupole (QQQ) mass spectrometer (GC-MS/MS)
  • LC – Triple Quadrupole (QQQ) mass spectrometer (HPLC-MS/MS) – Jet Stream Source
  • ICP-MS with LC-ICP-MS
  • Karl Fischer titrator
  • Density meter
  • Refractometer
  • Dissolution testing
  • Disintegration testing
  • Gravimetric analysis
  • Melting point apparatus
  • FTIR and UV spectroscopy
  • pH and Conductivity meter
  • Friability, hardness and thickness tester
  • Viscometer
  • Kjeldahl nitrogen analyser
Clear processes
& expectations

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.

Good communication
Combined with countless years of experience in pharmaceutical analysis, quality assurance and regulatory affairs, we are far more than just a testing laboratory. We are an accountable and innovative partner to our customers, going to new lengths to support your existing products or the registration of new medicines, formulations and dosage forms.
Honesty &
integrity
Even with the most advanced sytems in the industry, a contract testing laboratory can be made immeasurably better by its people. So at Pharmalytics we seek out professionals who are committed to personal excellence, and who are driven to encourage their teammates to achieve the highest standards they can, as well. When you engage our team to test and analyse your products, you can be assured you are bringing in the most exacting, skilled and ethical people in pharmaceutical analysis, quality assurance and regulatory affairs.
Regular updates
With a true end-to-end service, we will remove the headache commonly experienced in the analysis of your product and take on board the regulatory requirements, GMP compliance and most importantly, scheduling of results, to meet your timelines and deadlines.
Dr. Russell Kinghorn, Managing Director
Russell is a pioneer in the Australian Chemical and Pharmaceutical Analysis Industry, co-founding Chemical Analysis Pty Ltd in 2006. As managing director for over 10+ years, Russell grew the business at the time into the industry’s foremost testing resource. In 2018, following the sale of Chemical Analysis, Russell seized the opportunity to travel to some of Australia’s Iconic destinations. He’s a keen adventurer, photographer and cyclist. But with a wealth of knowledge, a passion for innovation and rolodex full of the industry’s most in-demand talent, Russell was always going to go on to bigger and better things in chemical and pharmaceutical analysis.  Russell is proud to have founded Pharmalytics in 2019.
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Carmen Louey, Quality Manager

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.

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Tameka Naismith, Laboratory Manager

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.

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TGA Licence

MI-2019-LI-09504-1

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GMP certificate>
APVMA Licence

6224

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US FDA
FEI: 3016044111
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