NEVER MISS THESE WHILE WRITING THE “COMMON TECHNICAL DOCUMENT (CTD) FOR PHARMACEUTICAL”

Never miss these while writing the "​Common Technical Document (CTD) for Pharmaceutical​"

© 2017-2018 All Rights Reserved, No part of this document should be modified/used without prior consent PEPGRA Healthcare Pvt Ltd INDIA: Nungambakkam, Chennai, 600 034.

UK: The Portergate, Ecclesall Road, Sheffield, S11 8NX. Email:info@pepgra.com, Web:www.Pepgra.com.

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 Documentation(CTD) 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 © 2017-2018 All Rights Reserved, No part of this document should be modified/used without prior consent PEPGRA Healthcare Pvt Ltd INDIA: Nungambakkam, Chennai, 600 034.

UK: The Portergate, Ecclesall Road, Sheffield, S11 8NX. Email:info@pepgra.com, Web:www.Pepgra.com.

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

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Module 1​ : Administrative information and prescribing information;

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Module 2​ : Overviews and summaries of Modules 3–5;

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Module 3​ : Quality (pharmaceutical documentation);

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Module 4​ : Non-clinical reports relating to pharmacology, toxicology

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Module 5​ : Clinical study reports (clinical trials).

© 2017-2018 All Rights Reserved, No part of this document should be modified/used without prior consent PEPGRA Healthcare Pvt Ltd INDIA: Nungambakkam, Chennai, 600 034.

UK: The Portergate, Ecclesall Road, Sheffield, S11 8NX. Email:info@pepgra.com, Web:www.Pepgra.com.

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 about 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 Pepgra is a quality-driven Contract 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 offers complete assistance to the pharmaceutical and medical device companies to develop scientifically accurate CTD document and has extensive experience in ➢ Full Dossier development o

Clinical overview (eCTD Modules 2.5) including Literature Review

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Module 2.3: Quality Overall Summary (QOS)

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Module 2.4/2.6: Non-Clinical Overview/ Summary

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Module 2.5/2.7: Clinical Overview / Summary

Thus, Pepgra can be 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.

About Author Dr.Nancy, Editor-in-chief, PEPGRA Healthcare Pvt Ltd​.

© 2017-2018 All Rights Reserved, No part of this document should be modified/used without prior consent PEPGRA Healthcare Pvt Ltd INDIA: Nungambakkam, Chennai, 600 034.

UK: The Portergate, Ecclesall Road, Sheffield, S11 8NX. Email:info@pepgra.com, Web:www.Pepgra.com.