HL Pharma Regulatory Services
HL Pharma offers comprehensive pharmaceutical services in Australia, including regulatory support, TGA registration, global sourcing, and temperature-controlled storage and distribution.
HL Pharma Regulatory Services is a specialized provider based in Melbourne, Australia, offering end-to-end solutions for the pharmaceutical industry. They facilitate TGA registration and sponsorship for both domestic and international companies, managing the entire process from dossier preparation to ongoing compliance. Their services extend to global sourcing of licensed and unlicensed medicines, including managing supply under the TGA Special Access Scheme (SAS) and other provisions for critical medical needs and shortages. HL Pharma also provides advanced temperature-controlled storage and cold-chain logistics, ensuring compliant handling of various pharmaceutical schedules and unregistered products. With a strong emphasis on quality, evidenced by their ISO 9001:2015 certification and adherence to GDP & GWP principles, HL Pharma acts as a trusted partner for healthcare providers, manufacturers, and sponsors. They manage complex supply chains, from import and warehousing to national distribution, ensuring products are safely and efficiently delivered throughout Australia and the APAC region.
About
**Who they are**
HL Pharma Regulatory Services is a pharmaceutical services provider based in Australia, established with decades of industry experience. They specialize in navigating the complexities of pharmaceutical supply chains and regulatory landscapes.
**Expertise & scope**
* End-to-end regulatory support for TGA market entry in Australia.
* Pharmaceutical and medical device registration and sponsorship.
* Coordination of regulatory strategy, dossier preparation, submission, and ongoing sponsor obligations.
* Support for post-clinical trial supply and managed access programs, including TGA Special Access Scheme (SAS), Managed Access Programs (MAPs), and Authorised Prescriber (AP) pathways.
* Pharmacovigilance and regulatory safety services, including adverse event handling and risk mitigation planning.
* Temperature-controlled storage and cold-chain logistics for commercial, clinical, and investigational medicines, including controlled substances.
* Global sourcing of medicines for the APAC region.
* Assistance with medication shortages.
**Reputation / proof points**
* ISO 9001:2015 certified Quality Management System.
* Holds an Office of Drug Control (ODC) import and export licence for narcotic and psychotropic substances.
* Operates to GDP & GWP best practices.
* Melbourne facility provides advanced temperature-controlled storage and cold-chain logistics.
HL Pharma Regulatory Services is a pharmaceutical services provider based in Australia, established with decades of industry experience. They specialize in navigating the complexities of pharmaceutical supply chains and regulatory landscapes.
**Expertise & scope**
* End-to-end regulatory support for TGA market entry in Australia.
* Pharmaceutical and medical device registration and sponsorship.
* Coordination of regulatory strategy, dossier preparation, submission, and ongoing sponsor obligations.
* Support for post-clinical trial supply and managed access programs, including TGA Special Access Scheme (SAS), Managed Access Programs (MAPs), and Authorised Prescriber (AP) pathways.
* Pharmacovigilance and regulatory safety services, including adverse event handling and risk mitigation planning.
* Temperature-controlled storage and cold-chain logistics for commercial, clinical, and investigational medicines, including controlled substances.
* Global sourcing of medicines for the APAC region.
* Assistance with medication shortages.
**Reputation / proof points**
* ISO 9001:2015 certified Quality Management System.
* Holds an Office of Drug Control (ODC) import and export licence for narcotic and psychotropic substances.
* Operates to GDP & GWP best practices.
* Melbourne facility provides advanced temperature-controlled storage and cold-chain logistics.
Additional information
HL Pharma Regulatory Services focuses on simplifying complex pharmaceutical supply chains for domestic and international companies seeking to enter or operate within the Australian market. They offer tailored solutions that encompass regulatory compliance, product registration, and secure distribution. Their services are designed to support various access pathways, including post-clinical trial supply and managed access programs, ensuring continuity of therapy for patients. Companies engaging HL Pharma can expect support in managing TGA post-market requirements and maintaining patient safety throughout the product lifecycle. Their operational base in Melbourne is equipped for specialized storage and logistics, adhering to stringent quality standards.
Key Highlights
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Offers end-to-end regulatory support for TGA market entry in Australia.
Source
“We assist domestic and international companies in registering and sponsoring products through the Therapeutic Goods Administration (TGA). HL Pharma coordinates regulatory strategy, dossier preparation, submission and ongoing sponsor obligations to support efficient, risk-managed market entry in Australia.”
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Provides advanced temperature-controlled storage and cold-chain logistics.
Source
“Our Melbourne facility provides advanced temperature‑controlled storage and cold‑chain logistics for commercial, clinical and investigational medicines, and holds an Office of Drug Control (ODC) import and export licence for narcotic and psychotropic substances.”
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Facilitates supply under TGA Special Access Scheme (SAS), Managed Access Programs (MAPs), and Authorised Prescriber (AP) pathways.
Source
“HL Pharma facilitates supply under the TGA Special Access Scheme (SAS), Managed Access Programs (MAPs), and Authorised Prescriber (AP) pathways, and manages import or local supply, temperature-controlled distribution, and documentation so that patients can remain on therapy during the transition to full registration.”
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Holds ISO 9001:2015 certification for its Quality Management System.
Source
“HL Pharma holds ISO 9001:2015 certification and offers secure, compliant storage and distribution for Australian clinical trials and commercial medicines, including controlled substances under Schedules 2, 3, 4, 8, and 9, unregistered pharmaceuticals, and speciality products.”
Certifications & Trust Signals
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ISO 9001:2015 certified Quality Management System.
Source
“HL Pharma holds ISO 9001:2015 certification and offers secure, compliant storage and distribution for Australian clinical trials and commercial medicines”
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Operates to GDP & GWP best practices.
Source
“Under his leadership, the company operates to the highest regulatory standards, including GDP & GWP best practices, as well as ISO 9001:2015”
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Holds an Office of Drug Control (ODC) import and export licence for narcotic and psychotropic substances.
Source
“and holds an Office of Drug Control (ODC) import and export licence for narcotic and psychotropic substances.”
Buyer Snapshot
Best for
- Companies seeking TGA registration and sponsorship in Australia.
- Organizations requiring specialized cold-chain logistics and storage.
- Businesses needing support with post-clinical trial supply and managed access programs.
How engagement typically works
- Tailored solutions for complex supply chains.
- End-to-end support from sourcing to distribution.
- Collaborative approach to regulatory strategy and market entry.
Typical deliverables
- TGA registration dossiers and submissions.
- Managed Access Program implementation.
- Pharmacovigilance reporting and safety oversight.
- Temperature-controlled warehousing and distribution.
- Sourcing of critical and hard-to-find medicines.
Good to know
- Best when requiring specialized pharmaceutical regulatory and supply chain expertise in Australia.
HQ:
Melbourne, AU
Languages:
English
Timezones:
Australia/Sydney
Status:
listed
Services & Capabilities
AU TGA Sponsor Services
Jurisdictions:
AU
Countries:
AU
Industries:
Medical devices, IVD
Portfolio:
6-25
Onboarding time:
10–14 days
Pricing model:
Retainer
Starting from:
AUD 5,500
Included services:
Change notification and variation assessment, Sponsor address and labeling review, Annual ARTG charge reminders and continuity planning, ARTG inclusion application preparation and submission
Supports Artg:
No
Evidence Review:
Yes
Australian Entity State:
Victoria
Recall Vigilance Support:
Yes
Fsca Recall Support:
No
Additional tga_sponsor_au Details
Supports Artg
Yes
Recall Vigilance Support
Yes
Australian Entity State
Victoria
Onboarding Steps
The company emphasizes providing tailored solutions and support at every step, from sourcing and regulatory compliance to logistics and distribution, suggesting a customized onboarding approach.
