Heighten The Confidence Of The Public With Safer, More Evidence Based Therapeutics
CompleMED Consulting, a member of QNIA (Queensland Nutraceutical Industry Association) brings you the latest news on how assured compliancy in Complementary Medicine provides a competitive edge.
(PRWEB) October 29, 2005 -- QNIA, Queensland Nutraceutical Industry Association, is a non-profit organisation based on the Gold Coast, Australia. QNIA, (http://www.qnia.com.au) provides education, networking and opportunities for business growth for its members. Matthias Manicaros ND of CompleMED Consulting is a member of QNIA and bring you this latest news:
Assured compliancy provides a competitive edge
“A changing of the old guard. The birth of a new era. Weeding out the rogues.”
Call it what you will. It is unquestionable that the Australian Complementary Medicine industry has experienced an unprecedented evolution in the way it functions & the way we, as healthcare providers, operate within it.
The Regulatory & Technical environment has been singled out as an area requiring tighter controls. This distinction affects the many complexities of operations; from raw material supply, production procedures, in-house quality steps, to how, what & to whom we advertise.
Clearly, this re-structuring is designed for Sponsors to become more accountable for their consumable products & more responsible for the context in which they are sold. Meaning, it is a new set of standards we are required to meet & is anticipated to be enforced vigilantly through post-market surveillance teams headed by the Australian regulators of medicines; the Therapeutic Goods Administration (TGA).
This challenge represents opportunity. These requirements afford us to ‘raise the bar,’ through the production of safer, more efficacious therapeutics with evidence-based claim substantiations. Together, we can heighten the confidence of the general public & practitioners through their ability to better identify compliant manufacturers & Sponsors of complementary medicines.
CompleMED Consulting focuses solely on complementary medicines & specializes in:
| | - Listing products onto the Australian Register of Therapeutic Goods (ARTG)
- Investigative claim substantiation, applying the appropriate Levels of Evidence
- Interpreting & retrieval of clinical evidence to support label & advertising claims
- Ensure TGA compliancy regarding product label presentation & advertising material
- Explore & initiate new product development concepts within specified timeframes
- Source qualified facilities to authenticate reference standards used in manufacturing complementary medicines.
- Liaise with raw material suppliers & co-ordination of contract manufacturing logistics
- Liaise with legal & intellectual property agents regarding trademark registration & patent protection
- Offer recommendations on stability programs & protocols
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Since our inception, we have developed a valued network of industry contacts; from licensed contract manufacturers, raw material suppliers, local & global distribution channels to analytical testing laboratories. We are also conscious of maintaining a respectful & trusting association with the TGA & other peak industry regulators.
By reviewing your objectives we can achieve a number of productive outcomes. These include, preventing additional costs associated with product compliancy, reducing errors linked to artwork & promotional material & importantly, assist in maintaining market share to ensure brand profiling & product sales.
We are committed to assuring your products are in accordance with the current Australian Regulatory Guidelines & as a result, assist your business gaining a competitive advantage.
CompleMED Consulting is Sunshine Coast based & can be contacted on +61 7 5477 1191 or email mathias.m@ozemail.com.au I look forward to any inquiry you may have. You can find information on our organisation at http://www.qnia.com.au/member_info/complemed/complemed.htm.
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