Scientific Regulatory writing is a complex process due to its dossier size, data complexity, and submission deadlines and it requires specialized domain-specific knowledge, understanding of drug development process, pharmacology, statistical and writing skills to develop superior regulatory documents as per the exact requirements of the regulatory authority. Besides, the scientific writer must be familiar with technical guidelines prevailing in countries like European Union (EU), USA, Japan that includes ICH E3 to write clinical study reports, periodic safety reports (ICH E2C), publication guidelines (e.g. CONSORT, STROBE, PRISMA), the International Committee of Medical Journal Editors (ICMJE) guidelines for manuscripts.
Common Technical Document(CTD) for Pharmaceutical
The Common Technical Document (CTD) is an international standard for the summary documents relating to quality, safety and efficacy information of medicinal products. The CTD is mandatory for the registration of medicines. International Council for Harmonization (ICH) mandates to obtain regulatory approval of new drug applications of Pharmaceutical companies operating in European Union states. The main aim of CTD is to achieve greater harmonization in new drugs development and registration. The standard encompasses the entire spectrum of documentation to be integrated into a regulatory submission dossier, thereby offering complete guidance to pharmaceutical companies as to how formulation and manufacturing information supporting the quality parameter as well as the results of non-clinical and clinical research needs to be organized and presented.
While developing CTD dossier, the regulatory writer needs to possess a complete understanding of the various requirements and supporting documents in order to avoid getting rejected by the regulatory authority for missing important sections and resubmission.
Scientific Regulatory writing services offer great assistance to pharmaceutical companies in preparing high-quality CTD and its timely submission, resulting in early approval of new drugs from the regulatory authorities.
CTD dossier consists of five main modules
- Module 1: Administrative information and prescribing information;
- Module 2: Overviews and summaries of Modules 3–5;
- Module 3: Quality (pharmaceutical documentation);
- Module 4: Non-clinical reports relating to pharmacology, toxicology
- Module 5: Clinical study reports (clinical trials).
Important areas not to be missed in CTD document
Module 1 of CTD dossier needs to contain region-specific documents. Module 2 provides overview and summaries of modules 3, 4 and 5. This section needs to provide a general introduction to the new drug applied along with its mechanism of action and proposed clinical use.
Clinical summaries section needs to sum up information from individual studies including summaries and detailed study reports that focus on data summarization and integration.
It is advisable for the pharmaceutical companies to take the assistance of Scientific regulatory writers for writing clinical overview and a clinical summary section of module 2 of CTD dossier, as it requires both short summaries and detailed study reports.
About Pepgra Healthcare,
Pepgra Healthcare is a quality-driven Clinical Research Organisation (CRO) comprising advanced regulatory writers capable of delivering clinical study protocols and study reports in complete compliance with the ICH GCP guidelines. Pepgra Healthcare offers complete assistance to the pharmaceutical and medical device companies to develop scientifically accurate CTD document and has extensive experience in
- Full Dossier development
- Clinical overview (eCTD Modules 2.5) including Literature Review
- Module 2.3: Quality Overall Summary (QOS)
- Module 2.4/2.6: Non-Clinical Overview/ Summary
- Module 2.5/2.7: Clinical Overview / Summary
Thus, Pepgra can be an immense help in developing clinical trials for their new drug development process and Pepgra’s clinical trial scientific regulatory writers provide well-written documents resulting huge savings in time and money.
