Cyclone Pharmaceutical consultants is having expertise in Regulatory and GMP ,with practical aspects and practical knowledge our consultants are expert in their subject.Trust of client is our asset.
The Common Technical Document (CTD) is a standardized set of specifications for the application dossier used in the registration of medicines. It is intended to be utilized in Europe, Japan, and the United States, providing a uniform format for the submission of new drug applications to regulatory authorities in these regions. The CTD was created by the European Medicines Agency (EMA), the Food and Drug Administration (FDA), and the Ministry of Health, Labour and Welfare (Japan), and it is maintained by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
As part of the ICH process, guidance for the CTD has been developed for Japan, the European Union, and the United States, with the majority of countries adopting this format.
1. Administrative information and prescribing information
2. Common technical document summaries
3. Quality
4. Nonclinical study reports
5. Clinical study reports
Many small-scale manufacturers are confused about the differences between writing and compiling dossiers. Writing a dossier requires technical skills, such as studying and reviewing the client's technical documentation, whereas compiling a dossier is simply document formatting, which can be done by anyone without technical experience. With the help of its knowledgeable industrial workforce and competent technical staff, CPPL guarantees total compliance with regulatory standards.
The Pharmaceutical Consultants of India will assist you at every step of the way with all of your regulatory compilations, document development, and submission Cyclone Pharmaceuticals Pvt Ltd.In contrast to other consultants, our team includes members from the QA, QC, Production, and Regulatory sectors; therefore, document inspection, dossier building, and query answering are ultimately the simplest tasks for CPPL.
Cyclone Pharmaceuticals offers established regulatory consulting services that are both highly quality and reasonably priced.Regulatory agencies have frequently accepted our generated documentation without a single question. The CPPL team provides flawless Drug Dossier, DMF, CTD, ACTD, KDMF, USDMF, eCTD, EUDMF, USDMF, and other format creation. They are constantly on the lookout for new updates in laws.