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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 Subsure supports clients in

  • BulletManaging Global Submissions
  • BulletAssess the impact of proposed changes in terms of countries impacted, ongoing regulatory procedures, resources required
  • BulletCoordinate with manufacturing sites and Regional Regulatory teams on regional data/requirements
  • BulletCross-function, cross-country and cross-vendor coordination for required information
  • BulletCreate review for Regulatory submission content for all the submissions
  • BulletAuthor HA compliant Dossiers
  • BulletLiaise with Health Authorities
  • BulletSubmission 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.

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