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The Regulatory team at Kendle is one of the most experienced groups operating in Australia. Individual expertise includes developmental pharmaceutical chemistry, preclinical development, devices, regulatory strategies (local and international markets) and core dossier compilation.
Since the company's inception in 1994 as Synermedica, the group has been involved in all aspects of regulatory activities for a large number of clients.These have included Australian companies, international companies without an Australian presence, and Australian subsidiaries of international companies.
Regulatory activities include review and compilation
of Applications to the Australian and New Zealand authorities covering a wide range of therapeutic areas. We have been involved in conversion of FDA NDAs to Australian files, compilation of Common Technical Documents (CTDs) and orphan drug
applications. We are also active in providing expert advice for pre-ADEC responses and Ministerial appeals. We work closely with the Development & Commercialization Group, and advise on regulatory strategy for both local and international markets.
Working relationships with overseas regulatory agencies such as the FDA and EMEA and links with our network of regulatory experts within Kendle in the USA and Europe, ensure a comprehensive global perspective of regulatory requirements.
Our Regulatory personnel form an experienced and knowledgeable team who can offer a comprehensive range of Regulatory services for drugs, biologicals and devices, across a wide range of therapeutic areas, including:
- Applications to Register
- Literature Based Submissions (LBS)
- Re-scheduling submissions
- PI and CPI/CMI development
- Appeals (Ministerial and AAT)
- Global strategy development and advice
- Regulatory gap analysis
- OTC/complementary medicines listings
- Devices
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