Australia Regulatory Services

Welcome to Satori OCS's Australia Regulatory, Registration, and Licensing Services. Our comprehensive range of services is designed to assist you in navigating the intricate regulatory landscape of the Therapeutic Goods Administration (TGA) and the Australian Register of Therapeutic Goods (ARTG). With our expertise and dedication to excellence, we ensure that your products meet the stringent standards set by the Australian authorities, enabling successful market entry and operation in Australia.

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TGA (Therapeutic Goods Administration)

The TGA is the regulatory body in Australia responsible for regulating therapeutic goods. It operates within the Australian Government Department of Health and is responsible for evaluating, approving and monitoring the safety, quality, and efficacy of medicines, medical devices, vaccines, blood products and other therapeutic products for use in Australia. It is also responsible for regulating the supply, import, export, manufacture, and advertising of therapeutic goods. The TGA ensures that these products meet appropriate standards before they can be legally marketed and sold in Australia. The TGA also works closely with other regulatory agencies in Australia and with international regulatory agencies to ensure that therapeutic goods meet global standards for safety and efficacy.

The main functions of the TGA include:

Evaluation and registration of therapeutic goods before they can be marketed in Australia.
Monitoring and surveillance of the safety, quality, and efficacy including the investigation of adverse reactions and side effects of therapeutic goods once they are on the market in Australia.
Regulation and control of the manufacturing, import, export, and supply of therapeutic goods in Australia.
Enforcement of regulations related to the labeling, packaging, and advertising of therapeutic goods in Australia.
Providing advice, guidance and information to healthcare professionals, patients, and the public on the safe and effective use of therapeutic goods.

ARTG (Australian Register of Therapeutic Goods)

The ARTG is a database maintained by the TGA that lists all therapeutic goods that are approved for supply in Australia. It includes medicines, medical devices, and other therapeutic products that have been assessed and found to meet the necessary regulatory requirements. Being listed on the ARTG is a prerequisite for a product to be legally supplied in Australia.

Before a product can be included in the ARTG and legally marketed in Australia, it must go through the regulatory assessment process conducted by the TGA to ensure its safety, quality, and effectiveness.

Categories of Products/Who can Register?

We offer services to the manufacturers of the following categories of products for registration under the Australian regulatory framework:

Pharmaceutical Companies
Companies intending to register pharmaceutical products, ensuring compliance with Australian regulatory requirements.

Medical Device Manufacturers
Entities seeking TGA approval for medical devices, from classification to post-market obligations.

Complementary Medicine Manufacturers
Organizations seeking TGA registration of complementary medicines in Australia.

Manufacturers of Biological and Vaccines
Companies interested in getting regulatory compliance and registration of biological products and vaccines in Australia.

Services We Offer and Our Approach

Regulatory Strategy and Consultation
Our experienced professionals develop a tailored regulatory strategy based on your objectives and provide regulatory consultation to ensure that your products align with the TGA regulatory framework. We begin with an in-depth consultation to understand your specific regulatory goals and product requirements.

Documentation and Registration Support
We help in documentation including preparing dossiers for product registration, and guiding you through the entire process.

Submission and Approval
We navigate the submission process and liaise with Australian authorities for approval.

Quality Assurance
Our experts help you ensure that your products meet the quality standards mandated by Australian regulatory authorities.

Ongoing and Post-Market Compliance
Our support extends to post-approval compliance, ensuring ongoing adherence to TGA regulations. We offer support in maintaining compliance with Australia's post-market obligations.

Reasons to choose Satori OCS

Expert team with regulatory knowledge.
Tailored solutions for unique needs.
Streamlined process for approvals.
Comprehensive support from consultation to compliance.
Global reach for market entry beyond Australia.

Navigating the Australian regulatory landscape can be complex, but Satori OCS can guide you towards regulatory success in Australia. Our experts help you in ensuring compliance of your products with Australian authorities' standards, enabling their successful market entry and operation. Contact Satori OCS for consultation and regulatory excellence guidance.

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FAQs

Q1. What services do Australian regulatory consultants offer to pharma companies?

Australian regulatory consultants provide services such as regulatory strategy development, preparation and submission of applications, quality assurance, labeling and packaging compliance, and post-market support.

Q2. What is the role of the Therapeutic Goods Administration (TGA) in pharmaceutical regulation in Australia?

The TGA is the regulatory authority responsible for overseeing the safety, quality, and efficacy of therapeutic goods, including pharmaceuticals, in Australia. It assesses and approves new drug applications, conducts inspections, and enforces compliance.

Q3. Can Australian regulatory consultants assist with generic drug approvals?

Yes, Australian regulatory consultants can assist pharmaceutical companies with the preparation and submission of applications for generic drug approvals, helping to streamline the process.