Over 400 pharma and biotech companies rely on MasterControl for connecting quality document and data processes that drive efficiency and actionable insights to help you accelerate breakthrough innovations.
The MasterControl product lifecycle excellence platform is designed to provide pharma and biotech companies a single source of truth for product quality data across the entire enterprise and the wider ecosystem. It helps ensure that all teams working in drug development, clinical, regulatory, quality, supplier, manufacturing and postmarket functions can access the information they need to do their jobs more efficiently and effectively.
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The FDA's Center for Drug Evaluation and Research (CDER) evaluates and approves all new drugs before they can be sold, provides health care professionals and the public with information about using medicines safely, and monitors existing drug products in the marketplace. Within the FDA, CDER has primary jurisdiction over the pharmaceutical industry.
Title 21 of the Code of Federal Regulations (21 CFR) contains a number of rules outlined by the FDA for the pharmaceutical industry throughout the various stages of drug discovery, research, manufacturing, and marketing. These regulations are well known in the pharmaceutical industry such as Good Laboratory Practices (GLP), Good Clinical Practice (GCP) and Good Manufacturing Practices (GMP) to name a few.
The European Medicines Agency (EMA), the hub of 40 regulatory bodies that constitute the European Medicines Network, evaluates applications for new medicines and grants centralized marketing authorization for certain types of medicines. Drugs that don't fall under the EMA jurisdiction are evaluated by individual member states using their national authorization procedures.
National regulatory bodies in Europe include Germany's Federal Institute for Drugs and Medical Device (BfArM), the U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA), and Switzerland's Swissmedic.
In Asia, Japan's Ministry of Health, Labour and Welfare (MHLW) enforces regulations affecting the pharmaceutical industry in that country, while the China Food and Drug Administration enforces the People's Republic of China's Drug Administration Law.
In addition to complying with rules enforced by national or regional regulatory bodies, pharmaceutical companies that compete in the global marketplace also typically comply with international standards such as the ICH Q10, a harmonized guidance for the pharmaceutical industry, the ICH E6 GCP Consolidated Guidance, and European Union GMP guidelines.
MasterControl allows users to access information and perform tasks using a tablet or a smartphone. Mobile access offers greater flexibility for users and helps boost overall efficiency and productivity.
Cloud technologies are a necessity for pharmaceutical and biotech companies. Those without access to its speed and adaptability will struggle to maintain a competitive edge. MasterControl isn't just a cloud-based solution. It's dedicated teams and specialized tools ready to make your transition simple and your experience seamless.
MasterControl provides an effective framework for a company's quality management system (QMS) by automating all documents- and forms-based processes, connecting all quality processes, and providing a web-based, centralized location for all documents.
The MasterControl Regulatory Excellence solution is designed to manage all documents, project tasks, and electronic submissions by Regulatory Affairs functional areas. The solution includes MasterControl EDM JumpStart, based on the DIA EDM Reference Model, which is an industry best-practice standard for ensuring completeness of Common Technical Document (CTD) formatted submissions. It provides a CTD-centric project management tool, a versatile platform that allows the storage of fully functional published output (including external hyperlinks, bookmarks, and xml file navigation) generated by publishing tools, and a secure, web-based environment for all regulatory submissions.
The MasterControl Clinical Excellence solution is designed to streamline clinical research processes by managing all documents, tasks, training, relationships, and audits throughout the clinical trial. The suite includes MasterControl TMF JumpStart, based on the DIA TMF Reference Model, which is an industry best-practice standard for ensuring completeness of clinical trial documentation. The suite also includes clinical quality forms to assist in the execution of clinical monitoring visits, clinical deviation, and clinical CAPA.