Product registration

Innovation

Newsflash

Sphere’s manufacturing facilities feature a high volume state-of-the art coating facility for tablets, soft gel capsules and hard shell capsules. Coating expertise includes both film and enteric coating with a variety of commercial batch size scales possible.

Product registration Sphere's Technical and Regulatory Affairs Department has the knowledge and resources to assist customers in the preparation of Registration Packages for both the Australian market and for export.

Though many international markets are difficult to enter because of restrictive regulatory regimes, our regulatory personnel have the experience that enables Sphere to supply products and regulatory support material to assist clients secure registrations in these markets.

Product monographs and reviews of scientific literature can be produced if required the sponsor.

While we don't provide a specific TGA listing service, we can assist you in the process by working closely with your TGA consultant.

Contact Sphere Healthcare customer service for further information.

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