Surrogate Sponsorship

Regulatory Concepts can help you by offering you the services of its related company Helex-A Pty Ltd to act as a “surrogate” sponsor during your initial steps of Australian regulatory submission related to medicines or devices.

Sponsor transfers

You may be looking to take on sponsorship of products already approved and included on the ARTG under an existing sponsor – under these circumstances you may want to know that the files are up to date and available for you to launch straight into marketing- Regulatory Concepts can assist you by doing a due diligence review or Gap analysis.

Due Diligence is the key to ensuring that you are covered and that there are no hidden surprises that will delay your marketing strategies or cost you more than you bargained for.

Whether it is one product or a whole business/product portfolio, Regulatory Concepts can provide you with the appropriate level of due diligence or Quality review/GAP analysis required to give you a report outlining what you need to do and the costs involved in order to eventually have  a product you can take to market.

We cover:

Medicines – at all levels – prescription, OTC, complementary, listings.

Devices– including medical devices, IVD’s disinfectants

Foods/Dietary Supplements and Cosmetics

Surrogate Sponsorship

In order to be able to submit an application in Australia for approval of a Medicine (prescription, OTC or complementary- Listings) or medical device (medical device, IVD’s, disinfectants) or request a GMP inspection or Clearance from the TGA(Therapeutic Goods Administration) you must be registered with the TGA as an Australian sponsor. This means you must either be an Australian resident or a registered Australian business.

However, the process of registration for prescription medicines and waiting for GMP inspections or assessments from the TGA can take a long time.
You may wish to get things started, while you take the time required to sort out the legalities of setting up an Australian entity or an agreement with an existing Australian sponsor.

Helex-A Pty Ltd is an independent company, who offer their services as a “Stand -in” or surrogate Australian sponsor to help you during the initial phases of your set up in Australia. Once you are ready to set up your own entity or agreement, any products registered in the name of Helex-A can be transferred to your new entity with a minimum of fuss.

Due Diligence

Due Diligence is the key to ensuring that you are covered and that there are no hidden surprises that will delay your marketing strategies or cost you more than you bargained for.

Whether it is one product or a whole business/product portfolio, Regulatory Concepts can provide you with the appropriate level of due diligence or Quality review/GAP analysis required to give you a report outlining what you need to do and the costs involved in order to eventually have  a product you can take to market.

We cover:

Medicines – at all levels – prescription, OTC, complementary, listings.

Devices– including medical devices, IVD’s disinfectants

Foods/Dietary Supplements and Cosmetics

Surrogate Sponsorship

Surrogate Sponsorship

In order to be able to submit an application in Australia for approval of a Medicine (prescription, OTC or complementary- Listings) or medical device (medical device, IVD’s, disinfectants) or request a GMP inspection or Clearance from the TGA(Therapeutic Goods Administration) you must be registered with the TGA as an Australian sponsor. This means you must either be an Australian resident or a registered Australian business.

However, the process of registration for prescription medicines and waiting for GMP inspections or assessments from the TGA can take a long time.
You may wish to get things started, while you take the time required to sort out the legalities of setting up an Australian entity or an agreement with an existing Australian sponsor.

Helex-A Pty Ltd is an independent company, who offer their services as a “Stand -in” or surrogate Australian sponsor to help you during the initial phases of your set up in Australia. Once you are ready to set up your own entity or agreement, any products registered in the name of Helex-A can be transferred to your new entity with a minimum of fuss.

Regulatory Concepts

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