In-Country Representation

In-Country Representation

Most regulatory agencies around the globe require representation within the country or region for foreign device and pharmaceutical manufacturers. Through our subsidiary offices and extensive industry network we are able to provide in-country representation in most major markets.

United States – US Agent

Flag_of_the_United_States.svgOur headquarters is based out of the Tampa area in Florida and we are setup to provide US Agent services for both medical device and pharmaceutical product manufacturers marketing devices in the United States.

European Union – Authorized Representative

EUUN0001While we have had an office in the United Kingdom for over 10 years we recently established an office in Germany to increase our presence in Europe with a focus on providing regulatory, quality management, and business development consulting to life-science startup companies in Germany and surrounding Member States. Additionally, this office will serve as Authorized Representative for manufacturers seeking to expand commercialization of health products to the European Union.

Australia and New Zealand  – Sponsor

ajwtech-regulatory-australiaWe have established offices in both Australia and New Zealand specifically to provide in-country representation as well as device registration. Both Therapeutic Goods Administration (TGA) in Australia and New Zealand Medicines and Medical Devices Safety Authority (Medsafe) require a “sponsor” to submit and account for medical device, pharmaceuticals, and dietary supplements. Similar to the Authorized Representative services ajwtech-regulatory-new-zealandin the EU we serve as the liaison between the authorities and the manufacturer, should any adverse events or recalls be initiated. Additionally, the sponsor is legally responsible for the devices placed on the market in these regions and therefore takes on additional visibility and collaboration with the authorities.

India

255px-Flag_of_India.svgWhile India has had a mature regulatory infrastructure for pharmaceuticals, The government has recently (2017) approved the new medical device regulations for the country and is set for full implementation by January 2018. Our office in Gujarat has been established for several years and is licensed as a wholesale distributor and provides India Authorized Agent for our clients seeking to perform clinical trials, CDSCO product registration, or distribution of medical devices and pharmaceuticals in India. Please do let us know if you have interest in marketing your product in this major healthcare consumer market.

Global Representation

Our extensive network of consultants and channel partners we are able to introduce and in most cases secure in-country representation in other global regulatory regions. Our partners have locations throughout Asia, Middle East, Africa, Latin America, and Russia.