A medicine is essential for treating a disease. Thus care has to be taken that it is safe to use, has high efficacy in treating a disease without any adverse side effects and that’s where a regulatory professional plays a role. Regulatory affairs is essential aspect of each industry for controlling safety and efficacy of […]
Various companies, organisations and healthcare are tracking key regulatory compliance trends and developments to be addressed in 2019. Regulatory compliance Regulatory compliance is created with intention to heighten scrutiny and positively impact the manner in which products or services are produced and delivered. Regulatory compliance provides guardrails with an overall mission to serve and protect […]
Pharmaceutical Regulatory Affair All aspects of the pharmaceutical industry related to products, processes, documentation, service delivery, research or testing procedures, manufacturing and packaging are guarded by regulations. The legislations are carved to pave the safest path for streamlined journey of the products from the company to the consumers in the market. These rules, guidelines and […]
Clinical trials have grown over the past few decades to identify safety and efficacy of novel inventions like medical devices, drugs, vaccines, dietary or nutritional supplements, etc. Regulatory career opportunities in clinical research have increased since regulatory function is important for availability of effective and safe healthcare products worldwide.
A regulatory medical writer is a technical communicator with writing skills that specializes in preparing documents to meet requirements of regulatory authority. A regulatory medical writer has to collect technical specifications from medical workers arrange the information and prepare documents in compliance with regulatory authority. Apart from a knowledge about technical processes regulatory writers must […]
Anyone who has an interest in the regulatory field must have a very pronounced love of detail. … While the regulatory elements of a job like this can be learned, if you can’t manage tiny nuances of data in a multigigabyte document, you’re in trouble. […]
What is the need for regulatory affairs? Have you ever wondered who protects public health by ensuring the quality, safety and efficacy of drugs we consume? We all know that a new molecule costs several millions of bucks. At the same time, lack of proper regulation of these drugs can cost several lives. Another thought […]