KD&A

Regulatory Advice for Medical Device and IVD Companies

Call us today +61 8 8271 2347

Partners and Links

Partners

Australian Healthcare Solutions

Australian Healthcare Solutions provides strategic market development solutions to companies wishing to grow their business.  The business provides solutions to companies with existing Australian operations, those wishing to enter the Australian market and start up companies wishing to commercialise.  Australian Healthcare Solutions also offers clinical trial support activities such as site management, technical support, patient recruitment and physician management.

 

 

Intative Medical Marketing

Intative specialises in strategy and marketing for medical technology. With emphasis on use of digital channels for online brand management and lead generation, Intative provides a range of services including business strategy, copy writing, collateral development, website strategy and online promotion.

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Medical Device Regulatory Advisors

Medical Device Regulatory Advisors, Inc. (MDRA) is a US based professional consulting firm, providing regulatory and quality systems assistance to small to mid-sized, domestic and international medical device and pharmaceutical manufacturing companies.

 

 

Priory Analysts

Based in the EU Priory Analysts offer regulatory services for all types of companies from start-up to globals, and cover the whole range of medical technology from ‘simple’ Class I devices through to the most complex and high risk Class III devices, active implantable and in vitro diagnostic devices. Priory Analysts offer authorised representative services.

 

 

Useful Websites

European Commission

Global Harmonisation Task Force

Therapeutic Goods Administration (TGA)

Food and Drug Administration (United States FDA)

Medicines and Healthcare products Regulatory Agency (MHRA UK)

Health Canada

ARCS Australia Ltd (previously the Association of Regulatory and Clinical Scientists)

KD&A Clients

Visit our Client List to access our clients websites