PEPGRA HEALTHCARE Private Limited

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 registratio