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SeerPharma Associates
Zektin Group
The Zektin Group is an Australian-owned group of companies providing specialist Engineering and Project Management Services to the Pharmaceutical Industry and various process industries.
Web site: http://www.zektin.com.au
Clinical Trials Victoria
The aim of Clinical Trials Victoria is to promote and facilitate the conduct of clinical trials in Victoria.
Web site: http://www.clinicaltrialsvictoria.com
Pharmchem Technical Services Pty Ltd
Pharmchem Technical Services Pty Ltd offers professional and independent consultancy services to the pharmaceutical industry that include:
Scientific and Regulatory Affairs
- Domestic and international regulatory affairs, (TGA, NRA, FDA, EC)
- Pharmaceutics
- Advice and QA audits (GMP, GCRP, GLP, GCPV)
- Expert reports on pharmaceutical and bioscience product development and formulation
- Audits for compliance with global best practices in pharmaceutical GMP and QA
- Critical appraisal of registration data to EMEA, TGA, FDA and NRA requirements
- Advice on formulation development of sterile and non-sterile therapeutic goods and related "bioscience" products
- Product development and pharmaceutical chemistry - sterile and non-sterile therpeutic goods and related "bioscience" products
- Assistance in solving manufacture of "problem products"
- Review of product development pre-registration data
- Evaluation of IP, pre-clinical, clinical and scientific data
- Technology transfer
Technical
- Advice and mentoring on technical and scientific affairs in chemistry, pharmaceuticals and related biosciences, e.g. formulation development of sterile and non-sterile therapeutic goods
- Methods development and validation, setting of material and product specifications
- Process development and validation
Intellectual Property
- Commercialisation of novel pharmaceutical and bioscience products
- Product and intellectual property evaluation - due diligence
- Expert reports on pharmaceutical compound, process and composition patents
- Expert reports on novel chemical compound patents
- Expert witness in international and Australian patent matters
Pharmchem Technical Services Pty Ltd contact:
Dr Philip A. Marshall, FRACI CChem
Director
Pharmchem Technical Services Pty Ltd
5 Libby Court
Tennyson
South Australia 5022
ph: +61 8 8355 6023
fax: +61 8 8355 6024
e-mail: pharmche@ozemail.com.au
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