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Applications to the TGA or Medsafe Archives - Archer Emery and Associates TGA Consultants

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Archer Emery and Associates TGA Consultants. Applications to the TGA or Medsafe. TGA Change Applications Variations and Notifications. Making changes to products can be a simple process that only requires you to notify the Therapeutic Goods Administration (TGA), or it can be a complex one that requires a full assessment and approval by the agency. What’s more, sometimes a change in one area can mean changes are also required in another that take…. Archer Emery TGA Consultants. TGA or Medsafe Applications.

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Product Specifications Archives - Archer Emery and Associates TGA Consultants

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Archer Emery and Associates TGA Consultants. Making sure your products meet current standards. The ‘finished product specifications’ set out the criteria your product must meet must meet at release (the ‘release specifications’) and the criteria your product must meet if it is tested at any time during its shelf life (the ‘expiry specifications’). If your product was ‘grandfathered’ or registered some time ago, the specifications may not reflect…. Archer Emery TGA Consultants. TGA or Medsafe Applications.

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Problems with Existing Medicines Archives - Archer Emery and Associates TGA Consultants

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Archer Emery and Associates TGA Consultants. Problems with Existing Medicines. Minimise damage by responding quickly and openly. Problems with existing medicines. No matter how good your quality and safety systems are, problems can still occur that are out of your control or too late to avoid. It could be contamination, or the wrong amount of an active ingredient in a product. Whatever it is, you need to have a plan to protect your consumers – and…. Archer Emery TGA Consultants. Scheduling & Switch.

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Scheduling & Switch Archives - Archer Emery and Associates TGA Consultants

http://www.archeremery.com.au/category/classification-of-medicines-and-substances

Archer Emery and Associates TGA Consultants. We know therapeutics regulation inside and out. Changing the status of a product from a ‘prescription only’ medicine to an over-the-counter medicine, or from a ‘pharmacy only’ medicine to open selling can dramatically change the fortunes of your brand. But it is a complex and demanding application process. You need to know about the relationship between State and Commonwealth laws and how…. Archer Emery TGA Consultants. TGA or Medsafe Applications.

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TGA Consultant - Alan Duff | Archer Emery and Associates

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Archer Emery and Associates TGA Consultants. Alan Duff’s experience covers 13 years in the industry and 21 years in the Therapeutic Goods Administration (TGA) most recently as Head of Post-Market Review of OTC Medicines. As a Senior Good Manufacturing Practice Auditor in the TGA, he audited many production plants in Australia and around the world and worked closely with regulatory agencies in numerous South East Asian countries as well as US FDA. He has run training in Australia and Overseas.

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Staff Training Archives - Archer Emery and Associates TGA Consultants

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Archer Emery and Associates TGA Consultants. Bring your team up to speed. Staff Training in TGA Regulation. Well trained regulatory affairs staff are a major asset to your company. But knowing the regulations is not enough. You need to know how to deal with the people who administer them. Our professional Staff Training courses are based on our senior consultants’ years of experience in training TGA staff and staff from other regulatory…. Archer Emery TGA Consultants. TGA or Medsafe Applications.

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Therapeutic Goods Administration Consultants - Archer Emery & Associates

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Archer Emery and Associates TGA Consultants. Use our knowledge and expertise to extend your regulatory team. We’re the Experts in Therapeutics Regulation. Archer Emery and Associates are a team of highly qualified, highly trained professionals. But our career experience goes beyond the therapeutics industry. We bring over 50 years’ experience working within the Therapeutic Goods Administration (TGA), at senior management level, to every project. It’s this rare inside knowledge that gives us an edge.

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TGA Consultant - Julie Emery | Archer Emery and Associates

http://www.archeremery.com.au/our-people/julie-emery

Archer Emery and Associates TGA Consultants. Julie Emery has worked in the pharmaceutical industry for over 15 years. She has 10 years Therapeutic Goods Administration (TGA) experience as Manager of the Client Services and Secretariat Unit in OTC Medicines and Manager of the Australian Register of Therapeutic Goods, as well as 4 years industry experience. Archer Emery TGA Consultants. TGA or Medsafe Applications. Scheduling & Switch. Problems with Existing Medicines. Find a specific topic.

registermedicaldevice.com.au

Register Medical Device in Australia with Acrapack

http://www.registermedicaldevice.com.au/medical-services-links.php

Call: 61 7 5641 0159. How we can help you. Industry associated links to international regulations. The links provided below may be of some assistance if you are looking to register your product in different countries. The Medical Technology Association of Australia. Http:/ scienceindustry.com.au/. Http:/ www.ivd.org.au/. Http:/ www.ausbiotech.org/. Http:/ eur-lex.europa.eu/en/index.htm. Http:/ eur-lex.europa.eu/en/index.htm. Wwwmhra.gov.uk/Howweregulate/index.htm. How to contact us. August 20, 2014.

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Devices Archives - Archer Emery and Associates TGA Consultants

http://www.archeremery.com.au/category/health-care-devices

Archer Emery and Associates TGA Consultants. Your device or IVD. There are several different systems regulating the different types of medical devices used in the healthcare sector. We can help you identify which devices are ‘medical devices’, which are ‘therapeutic devices’ and which are ‘in-vitro diagnostics’ (IVDs). We know the requirements for each category and we can help you ensure that you have the correct…. Archer Emery TGA Consultants. TGA or Medsafe Applications. Scheduling & Switch.