Global regulatory differences and constant changes to HA submission requirements even in the age of the Common Technical Document and the eCTD, is a challenge to Regulatory Operations teams for proper submission planning and execution.
MakroCare, over the years, has established flexible methodology and infrastructure, for fast and effective global submissions to Health Authorities globally. Whether they are clinical applications, market authorization applications or life cycle management, MakroCare is managing submissions in more than 100 countries. Our experts are connected to deliver integrated services across North America, Europe, and ROW with detailed knowledge of different local submission processes.
Through our shared resources and management techniques, MakroCare offers innovative value-added services which will help Regulatory teams in getting the scale in shortest possible time to manage uneven loads and ever changing Regulatory requirements.
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