Consultants

Company Location Expertise
LOGO ACRA Regulatory Services Pty Ltd QLD Medical Devices | Regulatory Affairs
LOGO Acrapack Pty Ltd Boonah, QLD Medical Devices | Product Development | Quality Systems | Regulatory Affairs | Training
LOGO Affinity Clinical Research Services Pty Ltd Perth, WA Clinical Auditing | Clinical Research | Compliance | Consulting Services | Data Management | Feasibilities | Medical Writing & Communications | Project management | Quality Assurance | Quality Systems | Site management | SOP Development | Study management | Training
AUSTRALIAN EXPORT & INDUSTRIALISATION ADVISORY CORPORATION PTY LTD Narraweena, Sydney & Tweed Heads, NSW
Neil Covey has over 33 years management experience working with the healthcare sector including a distinguished career in international medical companies such as Bayer, Astra and Knoll Pharmaceuticals. Chris Buck is an Economist, MBA and CPA, ATO registered R&D specialist, Technical Advisor to AusIndustry, Austrade and The Institute of Export with a track record of successfully supporting exporters and corporations undertaking R & D. Chris was also MD of a company that won Queensland ‘Exporter of the Year’ Award for small business for building Hospitals in Iran and the Pacific, Schools, Emergency Clinics and a UN Peace Keeping Camp in the Middle East.
LOGO Biointelect Pty Ltd Brookvale, Sydney Clinical Research | Commercialisation | Compliance | Consultants | Consulting Services | Drug Development Consulting | GCP Compliance | Health Outcomes | Market Access | Medical Communications | Medical Devices | Organisational Development | Product Lifecycle Strategies | Project management | Quality Systems | Regulatory Affairs | SOP Development | Strategic Review | Training
Biotech Regulatory Solutions Pty Ltd Sydney Biosimilar Product Development | Commercialisation | Compliance | Consultants | Consulting Services | Drug Development Consulting | GMP | Medical Communications | Medical Writing & Communications | Pharmacovigilance | Product Development | Project management | Regulatory Affairs | Scientific Affairs | SOP Development | Training
Sponsorship during evalaution
LOGO Capital K Consulting Pty Ltd PENNANT HILLS NSW Biosimilar Product Development | Market Access | Organisational Development | Product Lifecycle Strategies | Regulatory Affairs
LOGO Elizabeth Dale Consulting NSW Clinical Auditing | Clinical Research | Consulting Services | Feasibilities | Medical Devices | Monitoring | Project management | Quality Assurance | Site management | Study management
LOGO Emerald Corporate Group Sydney, NSW
Consultancy providing expertise in the following areas to assist healthcare companies to achieve successful market access for their medical technologies:-

- market access strategy

- health technology assessments

- pricing and reimbursement strategy

- health economics

- early commercial assessments and feasibility analyses

- advisory boards and event management services

LOGO ERA Consulting TOOWONG QLD GMP | Pre-clinical | Quality Assurance | Regulatory Affairs | Scientific Affairs | Training
LOGO Ethicsready Pty Ltd Australia Wide Clinical Research | Consulting Services | Site management
Human Research Ethics Document Services
Ian Boyd Consulting GIRALANG ACT Pharmacovigilance
LOGO Mediwrite Pty Ltd Sydney, NSW, Australia Consultants | Consulting Services | Medical & Pharmacy Education | Medical Communications | Medical Devices | Medical Writing & Communications | Project management | SOP Development
Medical writing, editing and research
O'Shea & Associates Victoria
LOGO Pacific Life Sciences Pty Ltd Torquay VIC
Product development; GxP; Quality Management; Safety & Efficacy; Project Management; Regulatory Affairs.
LOGO Pharma To Market Pty Ltd Australia Business with China | Commercialisation | Compliance | Consultants | Consulting Services | GMP | Local study regulatory sponsorship | Market Access | Pharmacovigilance | Quality Systems | Regulatory Affairs | Scientific Affairs | SOP Development | Strategic Review | Training
eSubmissions (eCTD & NeeS) Non-commercial product sponsorship eCTD Publishing software solutions (Lorenz partner)
LOGO Pharmout Pty Ltd All major cities in Australia
Architecture, Engineering, Quality Assurance, Quality Systems, Validation, Training and Technical Writing
Regulatory Par Excellence Neutral Bay, NSW Medical Writing & Communications | Pharmacovigilance | Regulatory Affairs
LOGO ReSQ Clinical Research DOVER HEIGHTS NSW
All aspects of Clinical Trials in Drugs and Devices; Training; Auditing; Monitoring
LOGO Robert Forbes & Associates Pty Ltd Second Floor, 98 Glebe Point Rd Glebe Sydney NSW 2037 Compliance | Consultants | Consulting Services | GMP | Medical Devices | Regulatory Affairs | Training
Marketing and product placement
LOGO Southern Star Research Gordon NSW
Our expertise includes Phase I – IV clinical trials and our staff have extensive experience across a wide variety of therapeutic areas, with a strong focus on oncology, neurology, anti-infectives, medical devices and early phase studies.

Study Feasibility; Site Identification / Selection; Project Management; Monitoring; Subject Recruitment; Local Safety Reporting; Medical Monitoring; Local Study Regulatory Sponsorship; General Clinical Research Consulting

LOGO The SPD Company Pty Ltd North Ryde, Sydney, AUS Compliance | Consulting Services | Drug Development Consulting | GCP Compliance | GMP | Medical Devices | Pharmacovigilance | Product Development | Quality Assurance | Quality Systems | Regulatory Affairs
eCTD facilities offered
LOGO TudorRose Consulting Melbourne VIC Commercialisation | Medical Devices | Quality Systems | Regulatory Affairs
Effective regulatory submissions, biotechnology and high technology products, orphan drugs, oncology, review of product pipelines and global development strategies, chemistry, manufacturing and control, medical device and prescription medicine development.
LOGO Wahoo Clinical Pty Ltd Sydney Clinical Auditing | Clinical Research | Compliance | Consulting Services | GCP Compliance | Medical Writing & Communications | Project management | Quality Assurance | Site management | SOP Development | Study management | Training
phase 1 facility set-up and management
LOGO WriteSource Medical Pty Ltd Sydney Consultants | Health Economics | Health Outcomes | Market Access | Medical & Pharmacy Education | Medical Communications | Medical Writing & Communications | Regulatory Affairs | Training
Yasmeen & Associates Doncaster, VIC Regulatory Affairs