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Regulatory Affairs Consulting Services
Regulatory Affairs
Medical Information and Drug Safety Service
New Business Development
We offer the wide range of consulting services to our clients such as:
Regulatory Affairs Strategy for Product Development and Commercialisation
Regulatory Gap Analysis and Dossier Bridging
New Product Registrations in Australia
Literature Based Submissions
Product Life-Cycle Management
Writing Clinical Study Reports, Summaries and Overview
We offer the wide range of consulting services to our clients such as:
Regulatory Affairs Strategy for Product Development and Commercialisation
Regulatory Gap Analysis and Dossier Bridging
New Product Registrations in Australia
Literature Based Submissions
Product Life-Cycle Management
Writing Clinical Study Reports, Summaries and Overviews
Writing Toxicology Study Reports, Summaries and Overviews
New Business Development
Medical Information and Drug Safety Service
New Business Development
We can prepare regulatory gap analysis with commercial flare for new business development purposes.
Based on our research and analysis of the regulatory dossier as well as other documentation and information in public domain about the competitors, we can recommend distinctive product positioning and strategy for your new product.
Medical Information and Drug Safety Service
Medical Information and Drug Safety Service
Medical Information and Drug Safety Service
We provide various drug safety and medical information consulting services in house or remotely.
We can assist with various Medical Affairs Projects
Design and Implement Internal Process and System
Prepare your organisaton for Drug Safety (Pharmacovigilance) Audits and Inspections
Exclusive Consulting Services
New Subsidiary / Affiliate
Start Up Company Infrastructure
Start Up Company Infrastructure
We are proud to have assisted 3 clients with establishing their Australian affiliate/subsidiary from ground up.
We have worked with large US and Swedish pharmaceutical companies as well as smaller medical device company in establishing their presence in Australia.
We have assisted with company registrations with ASIC, agreements for produ
We are proud to have assisted 3 clients with establishing their Australian affiliate/subsidiary from ground up.
We have worked with large US and Swedish pharmaceutical companies as well as smaller medical device company in establishing their presence in Australia.
We have assisted with company registrations with ASIC, agreements for product distribution with 3rd party suppliers and Regulatory Affairs registration of their products.
Start Up Company Infrastructure
Start Up Company Infrastructure
Start Up Company Infrastructure
We have proven track record for creating company infrastructure for our clients that meets requirements of Australian regulators and supports product distribution.
Some of our past clients had a support of their large mother companies overseas, and others were small family start up businesses.
No mater how big or small your company is, we
We have proven track record for creating company infrastructure for our clients that meets requirements of Australian regulators and supports product distribution.
Some of our past clients had a support of their large mother companies overseas, and others were small family start up businesses.
No mater how big or small your company is, we are able to set up systems and processes for your organisation that will meet Regulatory Affairs requirements, pass Pharmacovigilance audit and support Medical Affairs. They will be tailored to your type of products.
Regulatory Affairs Coaching
Start Up Company Infrastructure
Regulatory Affairs Coaching
We offer unique Regulatory Affairs coaching to selected clients who may be under increasing pressure to achieve commercial goals with their existing resources, or are looking for innovative approach to Regulatory Affairs management.
We work very closely with our clients to truly transform their regulatory human capital and operations int
We offer unique Regulatory Affairs coaching to selected clients who may be under increasing pressure to achieve commercial goals with their existing resources, or are looking for innovative approach to Regulatory Affairs management.
We work very closely with our clients to truly transform their regulatory human capital and operations into an agile and modern function that serves the business growth and needs.
Dear Valued Clients and Partners,
RegulatoryEdge is evolving into HILAXON Pty. Ltd. Click to learn more about our journey and what this means for you.