Royal Australian Chemical Institute
NSW Branch
Database of Consultants
Pharmchem Technical Services
Area of Consulting:
Expert Witness
Pharmaceutical
Organic Chemistry
Contact Details:
| |
5 Libby Court
Tennyson
SA 5022 |
| Phone : |
+61 8 8355 6023 |
| Fax : |
+61 8 8355 6024 |
| Email : |
pharmche@ozemail.com.au |
| Web URL: |
|
Profile:
Pharmchem Technical Services is a privately owned company established
in 1991 to provide independent assistance and advice to industry on a wide
range of issues. Dr Philip Marshall FRACI CChem has over 25 years experience
in the pharmaceutical industry having held senior management positions with
major pharmaceutical companies in research and development, manufacturing,
quality assurance, clinical research, regulatory affairs, technology transfer
and IP management. With a large client base, PTS services span small business
to large multi-national companies.
PTS CONSULTANCY SERVICES:
PTS offers knowledge, professional and independent consultancy services
to the pharmaceutical, bioscience, veterinary and cosmetic industries that
include:
Scientific and Regulatory Affairs
- Domestic and international regulatory affairs, (TGA, NRA, FDA, EC)
- Pharmaceutical chemistry
- QA audits on GMP, GCRP, GLP, GCPV
- Pharmaceutical, cosmetic and bioscience product development and formulation
- Regulatory submissions: pharmaceutical, OTC, complementary medicines
and veterinary products
- Audits for compliance with global best practices in pharmaceutical
GMP and QA
- Critical appraisal of registration data to EMEA, TGA, FDA and APVMA
requirements
- APVMA approved GMP Auditor
Product Development
- Advice on formulation development of sterile and non-sterile therapeutic
goods, cosmetics & toiletries, and related ¡§bioscience¡¨
products
- product development and pharmaceutical chemistry
- overcoming manufacture of ¡§problem products¡¨
- review of product development data pre-registration
- Evaluation of IP, pre-clinical, clinical and scientific data
- Technology transfer
Technical
- Technical & scientific affairs in chemistry, pharmaceuticals and
related biosciences e.g., formulation development of sterile and non-sterile
therapeutic goods, cosmetics & toiletries
- Methods development and validation, setting of material and product
specifications
- Process Development and Validation
Intellectual Property
- Expert reports on pharmaceutical compound, process and composition
patents (Australia and international)
NSW Branch Special Interest Groups
NSW Branch home page.
Last Revised: 16th May 2007