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Product Registration

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Product Registration

Product Registration

Drug product registration is the process by which pharmaceutical companies seek approval from regulatory authorities to market and sell their drugs within a particular country or region. This process is crucial to ensure that drugs meet rigorous safety, efficacy, and quality standards before they are made available to patients. The data is submitted by the Pharmaceutical Company for the Registration of the Drug Product. The Inventor Needs to Conduct the Preclinical, Clinical, Bioequivalence Studies with approval of the Regulatory bodies of the respective countries. 

The data for the product registration is submitted in the dossier format of eCTD in various countries. The various modules of the CTD clarify the different type of the Data pertaining to the Drug like CMC data, clinical data, Preclinical data. Modules of eCTD are:

Module 1- Administrative Information and Regional Information

Module 2-Summaries

Module 3- Quality Data

Module 4-Non-clinical Data

Module 5-Clinical Data

The timeline for the drug registration is different for the different countries depending on the evaluation process of Application. Each regulatory authority has department for the evaluation. The regulatory authority performs the onsite inspection of manufacturing facility.

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Don’t let regulatory hurdles hinder your cosmetic product launch. Partner with OMC Medical for comprehensive registration and  notification services. Contact us today to learn more about how we can support your compliance needs and help you bring your cosmetic products to market successfully.

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