Regulatory Consulting & Strategy Services

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


With over 15 years of rich experience, we can help you solve the Regulatory puzzle 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. We have built a successful track record of timely and extensive approvals.

MakroCare can help you:

  • Offering advice on industry trends and current market needs.
  • Designing Regulatory Strategy for successful and efficient development and approval of your product in US, Europe (CP, DCP, MRP & NP), Japan & ROW.
  • Advice on Regulatory Strategies to meet the requirements of different Regulatory Authorities across the Globe.
  • Incubation of Global ambitions by formulating international-bridging strategies.
  • Advice on Regulatory Affairs and Regulatory Operations Outsourcing.
  • For regulatory advice please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

Have Questions? Need Info/Quotes?


Have Questions? Need Info/Quotes?