Pharmaceutical Product Registration

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. For the Registration of the drug product in each country has registration fee according to the protocol of the regulatory authority of the country. OMC Medical can help the pharmaceutical industry to register their product across the globe, providing the expert guidance and valuable support throughout the regulatory pathway from industry to market. The navigating point where you will get all types of the information services for registration a product.