Global Regulatory eCTD and Submission Management Services
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.
MakroCare through its Sub sure supports clients in:
- Managing Global Submissions
- Assess the impact of proposed changes in terms of countries impacted, ongoing regulatory procedures, resources required
- Coordinate with manufacturing sites and Regional Regulatory teams on regional data/requirements
- Cross-function, cross-country and cross-vendor coordination for required information
- Create review for Regulatory submission content for all the submissions
- Author HA compliant Dossiers
- Liaise with Health Authorities
- Submission and Approval
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