The Common Technical Document (CTD) is a set of specification for application dossier for the registration of Medicines and designed to be used across Europe, Japan and the United States. It is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries. It was developed by the European Medicines Agency (EMA, Europe), the Food and Drug Administration (FDA, US) and the Ministry of Health, Labour and Welfare (Japan). The CTD is maintained by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
Through ICH process, the CTD's guidance have been developed for Japan, European Union, and United States. Almost Most of the countries have adopted the CTD format. CTD is a set of specification for application dossier for the registration of Medicines and designed to be used across Europe, Japan and the United States.
CTD Contains:The eCTD has five modules:
Administrative information and prescribing information
Many Small scale Manufacturers are confused with Dossier compilation and dossier writting,writting dossier is a technical skill and it involves study and review of technical documents of Client and compilation is just a document formating skill which can be handled by any non techincal person.CPPL assures complete compliance of regulatory norms with its strong technical staff and knowledge gained throughout their industrial experiance
In your all kind of regulatory compilations,creation of documents and submission Cyclone Pharmaceuticals Pvt Ltd,the Pharmaceutical Consultants of India will help at every stage.Unlike other consultants we have team with QA,QC ,Production and Regulatory sector so review of documents ,compilation of dossiers and Query answering is ultimately easiest task for CPPL
Regulatory consultancy services of Cyclone Pharmaceuticals are proven services with highest Quality and Lowest cost.Our compiled documents many times are being accepted by regulatory authorities without single query. CPPL team is always alert for new updations in regulations provides perfect Drug Dossier,DMF,CTD,ACTD,KDMF,USDMF.eCTD,EUDMF,USDMF and other format compilation
Why to Choose CPPL as your Regulatory and Dossier Partner
Knowledge of Pharmaceutical Technologies
Knowledge about formulation and analytical techniques
Minimises time of registration with it's Perfect dossier service
Complete Support for Generating documents like PV,AMV,Stability
Comparativelly very Low Cost (Do not compaire with computor operators who provide Dossiers free of cost)
Honest servives ,we says yes if it is possible and no if having any difficulties
To serve Pharmaceutical Industry with best quality services and to bring a Quality culture in Documentation and regulatory services
Note : CPPL The best regulatory service providers of India do not compete with any other service providers because we know we are best