Regulatory affairs managers analyze data from clinical trials or from the research  and development process and determine the efficacy of a pharmaceutical drug or medicaldevice. They must ensure that an organization's product abides by the regulatorystandards outlined by the FDA or ICH. The regulatory affair professionals are required in areas of clinical trial approval,product registrations, regulatory writing, regulatory publishing, regulatory consulting, legal representation and others. The role of regulatory affair official usually lies inensuring companies compliance with various regulations and laws; coordinating with global and local regulatory agencies and advising on the regulatory aspects related toproposed projects. The major responsibilities of these professionals are providingregulatory consultation, formulating drug development strategies, product dossiers, conducting gap analysis, submitting reports,communicating with regulatory agencies and providing training related to regulatory affairs.

Pharmacovigilance is the process and science of monitoring the safety of medicines and taking action to reduce the risks and increase the benefits of medicines. Pharmacovigilance, also known as drug safety, is the pharmaceutical science relatingto the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products.pharmacovigilance is concerned with identifying the hazards associated with pharmaceutical products and with minimizing the risk of any harm that may come to patients. Companies must conduct a comprehensive drug safety and pharmacovigilance audit to assess their compliance with worldwide laws, regulations, and guidance.

Clinical data management (CDM) is the process of collecting and managing research data in accordance with regulatory standards to obtain quality information that iscomplete and error-free.Clinical data management ensures collection, integration and availability of data at appropriate quality and cost. It also supports the conduct, management and analysis of studies across the spectrum of clinical re earch as defined by the National Institutes of Health (NIH). The ultimate goal of CDM is to ensure that conclusions drawn fromresearch are well supported by the data. Achieving this goal protects public health and increases confidence in marketed therapeutics.

Medical writing involves writing scientific documents of different types which include regulatory and research-related documents, disease or drug-relatededucational and promotional literature, publication articles like journal manuscriptsand abstracts, content for healthcare websites, health-related magazines or news. A medical writer, also referred to as medical communicator,[1] is a person whoapplies the principles of clinical research in developing clinical trial documents thateffectively and clearly describe research results, product use, and other medicalinformation. The medical writer develops any of the five modules of the CommonTechnical Document. The medical writers also ensure that their documents complywith regulatory, journal, or other guidelines in terms of content, format, and structure.