Boutique consulting company with focus on value creation for clients across Pharmaceutical, Biologicals, Medical Devices and Cosmetic Industry. We provide expert regulatory affairs, business development, drug safety, and medical information services.
Our approach involves partnering closely with our clients to navigate the intricate landscape of regulations and competition, ensuring efficient and successful product launches, and fostering sustainable business growth.
Our passion lies in transforming lives through facilitating access to quality medical care encompassing early detection and preventative measures, as well as various treatment modalities. With deep expertise in the Australian market and a global perspective, we are your strategic ally in achieving a future where everyone has the opportunity to live a healthy, fulfilling life.
Broad Expertise
Our expertise extend beyond pharmaceuticals and encompass Prescription Medicines such as small molecules, biotechnology products and biologicals (e.g. faecal microbiota transplant, tissue-based and cell-based products), OTC - Over the Counter Medicines, Medical Devices and Cosmetics.
Some of the specialised services we offer are:
• product development and commercialisation
• regulatory affairs strategy
• regulatory gap analysis and dossier bridging
• new product registrations in Australia
• literature based submissions
• product life-cycle management
• pharmacovigilance
• process design and implementation
• Clinical Study Reports, Summaries and Overviews
• Toxicology Study Reports, Summaries and Overviews
We work across strategy, R&D, operations, and commercial fields to assist our clients with challenges in areas such as:
• create distinctive products in a crowded marketplace
• achieve the best regulatory outcomes for new products
• achieve growth in Australian marketplace
• navigate healthcare and regulatory reforms
• establish Australian affiliate / subsidiary
email: info@regulatoryedge.com.au
Company Details
- Founded
- -
- Address
- 119 Willoughby Rd, Crows Nest,new South Wales 2065,australia
- Industry
- Professional Services
- NAICS
-
Professional, Scientific, and Technical ServicesArchitectural, Engineering, and Related ServicesOther Professional, Scientific, and Technical ServicesLandscape Architectural ServicesEngineering ServicesDrafting ServicesBuilding Inspection ServicesGeophysical Surveying and Mapping ServicesSurveying and Mapping (except Geophysical) ServicesTesting LaboratoriesAll Other Professional, Scientific, and Technical Services
- Website
- regulatoryedge.com.au
- Keywords
- Regulatory Strategy, Product Development and Commercialisation, Pharmacovigilance Process Design and Implementation, Regulatory Gap Analysis and Dossier Bridging, Literature Based Submissions, Clinical Study Reports, Summaries and Overviews, New Product Registrations in Australia, Toxicology Study Reports, Summaries and Overviews, Product Life-Cycle Management, Prescription Medicines, OTC Over The Counter Medicines, Cosmetics, Medical Devices, Start ups, Biotechnology products, Tissue-based products, cell-based products, Faecal microbiota transplant, Regulatory Submissions.
- HQ
- Crows Nest, New South Wales
- Competitors
- BioU Medical, Echo Therapeutics ANZ.
Regulatoryedge Questions
Regulatoryedge's website is regulatoryedge.com.au
Regulatoryedge's LinkedIn profile is https://au.linkedin.com/company/regulatoryedge
Regulatoryedge's industry is
Professional Services
Regulatoryedge's top competitors are
Biou Medical,
Echo Therapeutics Anz.
Regulatoryedge's categories are Professional Services
Regulatoryedge's founding year is 2017
