ICP Firefly Pty Ltd
Overview
ICP Firefly Pty Ltd, established in 1995, is an independent Australian contract research organisation operating under the direction of Dr Isabelle Meyer-Carrive.
Our mission is to add value to your project by providing professional preclinical toxicology and ecotoxicology services, and working in collaboration with researchers to achieve desired outcomes.
Through the use of specialised infrastructure and in-house expertise across all facets of preclinical and ecotoxicology, we can provide a service tailored to yield the maximum information and meet the most stringent international regulatory requirements.
International certification such as Good Laboratory Practice (GLP) (NATA accreditation no. 14320) and ISO9001 (NCSI certification no. 8116) have been obtained as required by regulations for the purpose of registering or licensing for use pharmaceuticals, pesticides, veterinary drug products and the regulation of industrial chemicals.
ICP Firefly is accredited as an Animal Research Establishment (ref. no. AW.96/042) with the Animal Welfare Unit of NSW Agriculture. An independent in-house ethics committee reviews each in vivo study to guarantee experiments are conducted with the highest scientific, humane and ethical principles.
Regulatory experts in Australia and the United States working with ICP Firefly verify the design of preclinical toxicology studies and packages to satisfy the requirements for submission to regulatory bodies. Submissions to the TGA, NICNAS and FDA can be made.
Competitive advantages
Core in-house competencies include:
- Acute, subacute and chronic toxicology by conventional routes in rodent, guinea pigs, lagomorphs and dogs.
- Fertility / Reproduction studies
- Clinical and histopathology component
- Ecotoxicology
- Tailor made experimental and study design for preclinical toxicology/efficacy studies
- Establishing new animal/cell models specific to the compound mode of action
- Pharmacokinetic / Toxicolkinetic studies
- Genetic toxicology (in vivo/in vitro)
- Drug optimisation studies
- Analytical chemistry for drugs and biologics analysis are performed using highly selective triple quad mass spectrometry detection with ultra performance liquid chromatopgraphy.
Main business focus/
Listing by sector:
- Service Provider
Competitive Advantages
All the studies are performed IN HOUSE in Australia, no studies are subcontracted. The pre-clinical packages are tailored for each compound in collaboration with the inventor. The studies can be audited by the Sponsor. We offfer the full package from drug optimisation to full GLP packages including histopathology and analytical chemistry.
Contact Details
| Contact person | DR Isabelle Meyer-Carrive |
|---|---|
| Job Title | Managing Director / CEO |
| Address | PO Box 6198 |
| City/Suburb | Alexandria |
| State | New South Wales |
| info@icpfirefly.com.au | |
| Phone | +61 2 9310 3899 |
| Fax | +61 2 9310 4889 |
| Website | http://www.icpfirefly.com.au |
