RIMS is a growing software category that streamlines the submission of human medical products—including pharmaceuticals, biologics, and medical devices—to regulatory agencies, ultimately to gain authorization to sell the said product in a given market. In general terms, Regulatory Information Management Software (also known as Regulatory Information Management Systems) are software systems that:
- manage product dossiers including regulatory product information,
- aid in the preparation of product submissions in regulated formats, and
- manage the submission of information in approved formats to regulatory agencies.
Regulatory information management consists of software solutions suiting to the respective industry and nature of business, especially for pharmaceutical, biotechnology, and clinical research industries. The software allows manufacturers and respective personnel in the aforementioned industries to ensure strict observance of complex regulations set by regulatory authorities in the respective regions.
The regulatory scenario in the industries such as biotechnology, pharmaceuticals, and clinical research tend to be highly critical and keeps updating at frequent intervals. This has led to development of competent regulatory information management to be adopted by industry players. This ever-changing regulatory scenario in such industries proves to be one of the important driving factors for adoption of regulatory information management software.
The key players covered in this study
Computer Science Corp (CSC)
Market segment by Type, the product can be split into
Market segment by Application, split into
Clinical Research Organizations
Market segment by Regions/Countries, this report covers
Central & South America
The study objectives of this report are:
To analyze global Regulatory Information Management status, future forecast, growth opportunity, key market and key players.
To present the Regulatory Information Management development in United States, Europe and China.
To strategically profile the key players and comprehensively analyze their development plan and strategies.
To define, describe and forecast the market by product type, market and key regions.
Irfan Tamboli (Head of Sales) – Market Insights Reports
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