ClinAudits
Mobile:
U.S.A.
Country:
+1 973 492 7343
Fax:
Website:
information@clinaudits.com
E-mail:
Ensuring domestic (FDA) and international regulatory compliance since 1994, ClinAudits has established a reputation for delivering best practices in GXP (GCP, GLP, GMP, GTP) auditing and consulting services. Designed to assist clients in the pharmaceutical, biotechnology and medical device industries, our breadth of services offers a unique blending that sets us apart from the vast field of CROs. ClinAudits has regional auditors in North and South America, Europe, Asia, Australia.
170 Kinnelon Road, Suite 17, Kinnelon, NJ 07405 U.S.A.
Address:
Auditing
+1 973 492 8108
Phone:
Cheri Wilczek, President
Contact Person:
CMC Regulatory
+61 (0)421 869 761
Mobile:
Australia
Country:
Fax:
Website:
davidedmonds@yahoo.com.au
E-mail:
Advises regarding Regulatory and GMP requirements and contents for TGA Module 3 submissions and human and veterinary medicine equivalents to other Agencies. Applicable for chemistry, manufacture, quality and stability for both active ingredient and therapeutic dose form.
Specialisation in requirements from drug discovery/early development through early clinical trials, setting of specifications with corresponding test methods and collation and review of chemical analytical laboratory data.
78 Tarrants Ave Eastwood NSW 2122 Australia
Address:
Regulatory Consultants
+61 (0)2 9858 2755
Phone:
David Edmonds, Principal
Contact Person:
RDDT Laboratories
+61 (0)417 535 617
Mobile:
Australia
Country:
+61 (0)3 9925 7020
Fax:
Website:
frances.guyett@rddt.com.au
E-mail:
Since being awarded its GLP accreditation in 2004, RDDT Laboratories is equipped to execute a range of toxicology studies (including genotoxicity, acute to chronic repeat dose studies etc) in various mammalian species in accordance to the appropriate regulatory standards. In addition, bioanalytical services and custom efficacy studies can be validated and performed to meet your needs. RDDT Laboratories also works closely with a number of partner CROs to provide services in non-mammalian species.
RMIT Drug Discovery Technology Pty Ltd Building 201, Level 2, Room 11, Bundoora West Campus Bundoora VIC 3083 Australia
Address:
Laboratories
+61 (0)3 9925 7091
Phone:
Dr Frances Guyett, CEO
Contact Person:
Merging Technologies Pty Ltd
Mobile:
Australia
Country:
+61 (0)2 9719 2811
Fax:
Website:
info@mergingt.com
E-mail:
Merging Technologies provides independent QA auditing and training with respect to Good Clinical Practice to ensure compliance with the internationally adopted ICH regulations.
Merging Technologies also conducts auditing on clinical trial conduct, compliance with Protocol, SOPs, and any applicable local or international regulatory requirement.
Merging Technologies QA Auditing Services for the clinical research industry.
Because clinical trials are about quality standards.
56-56A Thompson Street Drummoyne NSW 2047 Australia
Address:
Auditing
+61 (0)2 9181 1018
Phone:
John Edington, CEO
Contact Person:
Derming Australia Pty Ltd
Mobile:
Australia
Country:
+61 (0)2 9719 2811
Fax:
Website:
info@derming.com.au
E-mail:
At Derming Australia, we provide clinical evaluations on the tolerance and activity of skin care products based on scientific tests. We carry out dermatological studies and develop protocols which are tailored to our customer’s needs.
Derming was founded in Monza, Italy in 1993 and has extended operations in Sydney, Australia through Derming Australia in 2009.
Derming Australia is a private and independent research company specialised in clinical trials for skin, hair and nail products.
56-56A Thompson Street Drummoyne NSW 2047 Australia
Address:
Laboratories
+61 (0)2 9719 3852
Phone:
Emanuela Elia, Director
Contact Person:
