Food and Drugs Authority (FDA)
Yes
12-18 months
GHS 6,000 (around USD 1,000).
5 Years
Applications are classified into three categories:
This module includes detailed requirements for non-clinical study reports for new chemical entities. It outlines the specific data and information needed for the non-clinical evaluation of the drug’s safety and efficacy.
Module 5 provides guidelines for the submission of clinical study reports. It includes requirements for presenting the results of clinical trials, ensuring that the data is comprehensive and supports the safety and efficacy of the drug.
REQUIREMENTS
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Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
To launch a medical device in a country, medical devices must comply with the local country’s regulatory requirements. Let us be your trusted partner in bringing your medical devices to the Global market. Contact us today to learn more about how we can assist you in every step of the way.