Scientific Report /CMC Writing Services – Effective and Efficient option for Scientist Community
Scientific Writing is an integral part of drug development process as a massive number of documents & Reports are generated, including Dossier documents for Approval from Regulatory Agencies and wide variety of documents and reports that are needed for internal process control. Extent of writing puts considerable time burden on Scientists and their productivity is constrained.
Global-Value-Web offers an efficient option to assist them with Reports drafting / Writing, support for Dossier submissions and Master data management of product during its life cycle, in accordance with Global standards for Scientific Reports. GVW executes these services in several engagement modes to Global Enterprises with SMEs having necessary proficiency and authoring skills, and having considerable exposure to Global Regulatory Writing Requirements.
GVW has a vast experience in writing Master control documents such as Global Specifications, Test methods, Validation Reports, Stability Study Reports, Risk assessments, Material Qualification, Method Equivalence Reports and Change Control documents.
Apart from Scientific writing services, GVW has skilled professionals in assisting the regulatory team in the Development phase and preparation of eCTD documents. GVW focusses on the Quality Module 3 of the CTD covering the control documents (section 3.2) for Materials, Drug Substance, Drug Products and stability.