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Global Innovation & Regulatory Experts for Health & Wellness Products
Our Services: Compliance. Strategy. Global Launch Success.
Whether you’re preparing to launch in one region or twenty, our services are designed to eliminate regulatory guesswork and speed your path to compliance. Explore what HealthREG can do for your team:
Global Product Registration
We manage your submissions to authorities like TGA, FDA, EFSA, MHRA, and more. From documentation to communication, we help ensure a smoother approval process
Step By Step Guide
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Select your market(s) and product type.
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We identify documentation and regulatory pathway.
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Prepare and submit required dossiers or notifications.
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Liaise with authorities on your behalf and receive official approvals and market entry confirmation.
Sponsorship & Regulatory Representation
We act as your authorized representative or regulatory sponsor in Australia, EU, and other regions where local presence is mandatory for product registration and compliance.
Step By Step Guide
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Select your market and product category.
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We act as your authorized local representative with a contract in place.
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Fulfill regulatory contact and address requirements.
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Handle all government correspondence on your behalf.
Labeling & Claims Compliance
Review and approval of your packaging, labels, and marketing claims to ensure accuracy and legality across every target region .
Step By Step Guide
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Upload your label designs and marketing claims.
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We review per market-specific regulations.
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Highlight issues, banned terms, and formatting changes and provide annotated label with corrections.
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Final compliance sign-off before print or launch
Pharmacovigilance
Review and approval of your packaging, labels, and marketing claims to ensure accuracy and legality across every target region .
Step By Step Guide
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Enroll your product into our pharmacovigilance system.
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Establish a Safety Data Exchange Agreement (SDEA) and internal contracts signing.
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Onboard with your team for training and protocols to monitor safety signals, adverse events, and consumer reports.
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Maintain readiness for health authority inspections and audits.
Regulatory Strategy & Roadmaps
Custom roadmaps to streamline your global entry. We help classify your product, map regulatory timelines, and ensure your internal strategy aligns with external requirements.
Step By Step Guide
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Book a free strategy call
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Share your product details and target marketsescription text goes here
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We classify your product and assess risks
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You receive a customized roadmap with timelines and cost estimates.
Product Development & Innovation
We offer early-stage regulatory consulting, ingredient analysis, and market-aligned formulation guidance to help you create compliant, launch-ready products from the start.
Step By Step Guide
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Share your formulation concept or idea.
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We review feasibility based on regulations.
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Analyze restricted ingredients by region.
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Provide compliant formulation guidance..
