Chemical Analysis Pty Ltd   Overview Chemical Analysis employs the most advanced analytical equipment for meeting project diversity and timelines. With over 50 years combined industry experience for managing products through various stages of the life cycle - Discovery, Preclinical, Clinical and Post-market. The core strengths to the business complement the therapeutic and veterinary industries through; Bioanalytical method development, validation and quality control Pharmacokinetic screening of clinical trial material Management of Product Reverse Engineering projects Essential Similarity Testing for the registration of off-patent formulations Stability storage and assessment including Impurity Identification Chemical Analysis is contracted by many leading Pharmaceutical and Biotechnology companies within the Asia Pacific Region with a high incidence of return business, thus demonstrating the high Quality and Value of service provides. Business Opportunities (i.e Corporate Alliances/Partnerships) Chemical Analysis is looking for opportunities to provide analytical assistance for many industries.  It is particular focussed on addressing the ever changing needs and demanding deadlines of the Biotechnology and Pharmaceutical Sector. The key areas for opportunities cover Pre-clinial - Post-Market; Chemical and Bioanalytical method development and independent validation Stability Storage and Assessment with a focus on impurity identification Pharmacokinetic Analytical Screening Service – animal and human Raw Material Pharmacopeial Testing – USP, BP, EP, JP Product Release Certification Contribution to CMC programmes Emphasising both NCE and Biological drug types Specialising in the handling of general Cyto-toxic, Oncology, CNS and Diabetes research programmes Technology/Products and Services Description Available technology Nuclear Magnetic Resonance (multi-nuclear) 300 MHz NMR 500 MHz NMR with LC-NMR capability Mass Spectrometry 2 x QQQ LC-MS Instruments Single Quad LC-MS Time-of-Flight LC-MS (3ppm accurate mass) Ion-Trap LC-MS Chromatography HPLC with DAD / UV / RI / Fluorescence and ELSD Ion chromatography Preparative scale HPLC GC with MS (EI / PCI / NCI) / FID / NPD / FPD / ECD / Headspace / SPME ICH Compliant Stability Chambers (fully validated on-site) Temperature and humidity controlled Photostability Traditional Analytical Atomic Absorption Spectrometer and ICP Moisture, Polarimetery, pH, Melting Point, IR and UV spectroscopy Tablet Dissolution and Disintegration analysis Sub-visible particle assessment for parenteral solutions Cytotoxic drug testing capability Services Literature searching and preparation of protocols Analytical project management Analytical legal consultancy Competitive Advantages Flexible and efficient Quality system (Internationally compliant) Analytical data and methods acceptable to the FDA Rapid response, cost effective, transparent communication and full disclosure No IP issues Located within the Asia-Pacific Region All services located on a single site – no outsourcing without consent Website address: www.chemicalanalysis.com.au