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Regulatory Consulting & Strategy Services

It is difficult to separate your regulatory strategy from your business strategy. Getting the regulatory strategy right is important in ensuring the best possible outcome for both the patient and the company.


With over 15 years of deep experience, MakroCare can help you solve your Regulatory ambitions or challenges with innovative and customized solutions. We have a strong team of dedicated professionals with many years of industry and agency experience, who can tailor project plans to meet your regulatory requirements. Leveraging our Automation platform, you can further increase efficiency and improve productivity.

MakroCare can perform:

  • Bullet Designing Regulatory Strategy for successful development and approval of your product in US, Europe & ROW.
  • Bullet Advice on Regulatory Strategies to meet requirements of different Regulatory Authorities across the Globe.
  • Bullet Incubation of Global ambitions by formulating international-bridging strategies.
  • Bullet Advice on Regulatory Affairs and Regulatory Operations Outsourcing.
  • Bullet Life-cycle efficiency improvements to automate repetitive and manual processes.
  • Bullet Regulatory technology Integration.

For regulatory advice please contact us at

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