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Home
About Us
Our Team
Services & Expertise
Strategy Planning
Product Development and Standards
Regulatory Submissions
Re-scheduling / Re-classification Services
Postmarket Compliance & Surveillance
Regulatory and Administrative Appeals
Literature-Based Medicine Submissions
Biosimilar & Biotechnology Medicine Development
Due Diligence and Technical Assessment
Quality Management Systems
Authorised Representation, Sponsorship & Distribution Management
Reimbursement – Strategy, Advice and Submissions
Distribution Services
Diagnostics and IVDs
Biocompatibility
News and Articles
Events
Videos
Contact Us
Andrea Ives
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Recent Posts
When is a Standard Actually a Standard?
Jul 26, 2021
The bio pharmacy: market authorisations for protein-based medicines
Jul 12, 2021
Update on Notified Bodies designation under MDR / IVDR
Jul 2, 2021
MR Compatibility and Materials Science
Jul 1, 2021
Australia’s TGA releases updated Essential Principles Checklist
May 27, 2021
FDA & “Certain Devices” with Intact Skin Contact – Draft Guidance Assessment
May 25, 2021
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