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

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