Possesses a broad chemical knowledge.
Commercial involvement with chemical manufacturing industry.
In depth regulatory experience gained over 20 years in Australia and New Zealand.
Veterinary medicine and animal health expertise.
Hands on experience with TGA registrations for registrable and listable products.
Knowledgeable with NICNAS listing of chemicals and notifications.
Involvement with AQIS registrations for products in export meat establishments.
GHS/hazard classification speciality, label and safety data sheet compliance.
Strong client focus.
Stellina is an Associate Member of the Royal Australian Chemical Institute
Broad regulatory experience gained over 24 years in government and industry. Focus on creating regulatory solutions for the most difficult and interesting products. Has held senior APVMA roles (Pesticides Program, Data Protection, Fees Review, Senior Evaluator). Strong networks across industry. Has a Bachelor of Science degree with Honours from Australian National University in Canberra. Gavin has been with DTS since 2007.
Specialist in pesticide science, with extensive experience in researching various pesticide mechanisms at a molecular level. Experience with regulatory processes in China, Australia and New Zealand. Strong commitment to quality work. Knowledgeable with broad range of submission types. Worked as a consultant assisting companies in China and Australia. With her Chinese background and language skills Chang is well placed to assist clients, notably Asian suppliers, in securing regulatory approvals and compliance in Australia.
Initial work experience as a molecular biologist and parasitologist on various infectious disease projects in the UK. Joined the UK regulatory body, Chemical Regulations Directorate (CRD), with a role in the evaluation and authorisation of plant protection and biocides. Broad scientific background. Extensive UK and European regulatory knowledge. Strong focus on submission quality that meets regulatory requirements.
Very strong pharmaceutical, analytical and synthetic chemistry knowledge from across a range of disciplines. Broad experience in R&D with multinational companies. Involvement with discovery and development of novel mode of action pesticides with Sumitomo Chemicals in Japan. With the Institute of Chemical Research (Kyoto) was involved with the design and synthesis of new chiral chemical compounds for the drug industry. In the role of an APVMA external evaluator conducted scientific assessments relating to applications for approval of new active constituents and new manufacturing sites for existing active constituents.
Eunice’s background in horticulture led to involvement with nematodes and screening for resistance in sugarcane glasshouse and field trials. This level of plant protection knowledge greatly assists in understanding pesticide products. Knowledgeable and practical experience with NICNAS listing of chemicals, GHS/hazard classification, label, and safety data sheet compliance, TGA literature searches for complementary medicines. Great attention to detail, follow through with strong focus on submission quality that meets regulatory requirements and post registration compliance responsibilities. Eunice also is well versed in Chinese languages.
TGA Consultant with 15 years’ experience in clinical, research, product development and regulatory affairs. Specialises in herbal/natural medicines, medical devices and complimentary medicines. Registered Naturopath who is well skilled in ARTG requirements, NPD and health technical writing.
Nathan originally comes from a method development and clinical trial background. He has operated as a regulatory affairs manager across Australia and New Zealand for the past 14 years. During this time he has been responsible for the registration of a broad range of medical devices, medicines, chemicals and electronics. Nathan has successfully led and overseen multiple TGA conformity assessments. He has also successfully led the construction of manufacturing facilities and validations of these facilities in preparation for conformity assessment. He comes with a long history of managing the post market requirements and activities for therapeutics and devices.
Michael has been working in the commercial pharmaceutical and nutraceutical industry for 15 years as an analytical chemist/biochemist, performing tests on active analytes of medicinal drugs, multivitamins, nutritional supplements, herbal products, food matrices and agricultural feed samples. He has extensive experience in the use of analytical/chromatography instrumentation to conduct quantitative and qualitative analysis. He has also provided compliance and scientific data for regulatory affairs regarding TGA listings of AUST-L and AUST-R marketed products.
Strong financial and project management background. Focus on streamlining administration procedures and improving our client experience.
Focus on customer service and project management. Skilful in process improvement through the use of technology. Experience in a variety of industries and businesses across Queensland.