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Regulatory Support for TGA eCTD Submissions

Starting November 01, 2021, the Therapeutic Goods Administration (TGA) will begin a phased transition to Electronic Common Technical Document-only (eCTD-only) for all prescription medicines.

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Pharmaceutical Expertise

  • End-to-end Pharmaceutical Product Registration
  • Authorized Local Representation
  • TGA Manufacturing Site Registration
  • Market entry strategy and Market access intelligence
  • Act as QPPV (Qualified Person responsible for Pharmacovigilance)
  • Query Support Management till Approval
  • Pharmaceutical Lifecycle Management Support
  • Ad-hoc Regulatory Affairs Consultation
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Overview of the Australian
Regulatory Landscape

Australia’s Life Sciences industry covers biotechnology, pharmaceuticals, complementary medicines, medical technology (devices and diagnostics), and food & food supplements. In a view to aligning with international safety and Regulatory standards, the current Regulatory framework in Australia, though stringent enough, is set for a major facelift in coming years, challenging market entrants to navigate their operations.

With in-depth Regulatory knowledge, Freyr offers a comprehensive set of Regulatory affairs services and Regulatory affairs consulting aimed at assisting Life Sciences organizations to streamline operations and thus to achieve regional compliance.

 

Industries We Serve

Australia is one of the emerging global markets for pharmaceutical products. For distribution or marketing of medicinal products or drugs in Australia, manufacturers must obtain approval from the Therapeutic Goods Administration (TGA), the body responsible for enabling pharmaceutical products registration in Australia. With the recent development in mandates pertaining to labeling and submission formats, it is necessary for manufacturers/sponsors to keep abreast with the TGA regulations.

  • Regulatory Consulting
  • Regulatory Affairs
  • Publishing and Submissions
  • Medical Writing
  • Compliance, Audit and Validation
  • Pharmaceutical market access strategy
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Pharmaceuticals

The medical device market in Australia is well developed with a systematically defined Regulatory system. A major share of the medical devices used in Australia is imported, and the rest are manufactured by renowned global companies. The Therapeutic Goods Administration (TGA) regulates medical device registration in Australia. Under the purview of TGA, the Australian Regulatory Guidelines for Medical Devices (ARGMD) or the Australian medical device regulations are established, which is said to be similar in line with the European Union regulations.

  • Regulatory Strategy and Approach
  • Regulatory Market Support
  • Medical Device Registration and Approval
  • Quality Management System (QMS) Compliance
  • TGA Sponsor Representative Services
  • Medical Device Vigilance
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Medical Device

Food and Food Supplements is the largest manufacturing industry in Australia. The industry is very dynamic and gives paramount importance to the quality and safety of food products manufactured in and/or imported to Australia. Therefore, to ensure compliant market entry, manufacturers or importers must follow the Food Standards Code of Australia, especially in the aspects of ingredient safety, labeling and claims.

  • Regulatory and Technical Advice
  • Review of Existing Product Formulation Data and Ingredients for Inclusion on Listable Substances Database
  • Advice on the Eligibility of Ingredients and Finished Products along with the Level of Registration Required in Australia
  • Novel Food Ingredients and Novel Food Enquiry Submission
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Food and Food Supplements

The growing interest in personal care and increasing disposable incomes set the market growth of cosmetics in Australia on high. Cosmetics in Australia are classified as industrial chemicals and are regulated by the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) as per the Industrial Chemicals (Notification and Assessment) Act 1989 (ICNA Act). If the product’s primary function is sunscreen, then such product is regulated under Therapeutic Goods and Administration (TGA).

  • Cosmetics Registration in Australia
  • Product Classification
  • Ingredient Analysis
  • Regulatory Support
  • Label Assessment
  • Claims Review
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Cosmetics

Regulatory Technology

Freyr SUBMIT PRO
Freyr SUBMIT PRO, an eCTD Software, Suits All Your Submission Requirements
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Freyr rDMS
Freyr rDMS is an end-to-end electronic Regulatory Document Management System (rDMS/eDMS) exclusively designed to enable Regulatory data and documents in a compliant, efficient and intuitive manner.
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Freyr Label 360
Freyr Label 360 The Real-time is Now REAL Content To Carton
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Freyr PRISM
Freyr SPAR is one such RIM Solution that enables Life Science organizations to effectively manage the information right from tracking product registrations to generate statistical reports.
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About Freyr

Freyr is a leading, niche, full-service global Regulatory Solutions and Services Company supporting, Large, Medium and Small size global Life sciences companies, (Pharmaceutical | Generics | Medical Device | Biotechnology | Biosimilar | Consumer Healthcare | Cosmetics | Chemicals) in their entire Regulatory value-chain; ranging from Regulatory Strategy, Support, Dossiers, Submissions etc. to Post- Approval / Legacy Product Maintenance, Labeling, Artwork Change Management and other related functions.

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Our Regional Expertise

Being a Globally Local firm, we have our presence in the following countries, click to know more

Location

903/50 Clarence St,
Sydney NSW 2000
(9th level of building 50)

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