We follow exactly the regulartory services and requirements of the EU and we can categorically ensure you that we follow all EU Drug and medecine manufacturing Law at our factory in Bangladesh.
Complementary medicines in Bangladesh is regulated by the drug law which has the the strictestGuidelines for manufacturing and packaging of supplement than anywhere in the world.
Both our Product Development and Regulatory teams work closely with the TGA to ensure that we are up to date with all the required regulations under Australian law and any changes that may be occurring within the regulations.
Once a product is launched on the market, products must continue to comply with regulations and may be selected for post-market reviews.
Regulatory Services include:
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Both AUST L and AUST R product compliance |
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Product registration for Australian and overseas markets |
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Dossier collation and preparation |
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Regulatory assistance in international markets |
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Use of Permitted ingredients |
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Product specification development |
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Analytical method development and validation |
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Stability studies and shelf-life determination |
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Label compliance |
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Evidence packages and Claim substantiation |
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Post-market reviews |
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Allergen Statements |
