Post marketing surveillance is the process of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance. The drugs and medical devices are generally approved on the basis of clinical trials, which involves relatively a number of…
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The role of a medical device consultant is to identify the available options, take necessary corrective actions and prepare ways to deal with FDA to help the medical device manufacturers before introducing any device to the market. These consultants should be professionals and highly qualified in the field. But sometimes a few medical device consultants…
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OTC monograph is widely used as a rule book to detect the level of the OTC in the medicines. Nowadays, it is essential to take help from the monographs, so while having a treatment, it is essential to take help from the monographs that are really very important for you, as OTC drugs contain more…
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When your pharmaceutical company is working on a new project to develop new medicines, in this scenario, all they need is to take help from the pharmaceutical regulatory consulting company so that the project cannot face any burdens at this precious time. So, whenever you are choosing a pharmaceutical regulatory company that will help you…
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While working in the fields of medicine, getting certification is the much-needed thing that should be taken care of. In order to obtain certificates from the company, it is needed to have and follow some rules so that you will be able to gain the best results from the end of the service provider. Similarly,…
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The news regardless of the topic, the day, the place where you live; they have great importance for people’s lives, it is given by the set of communication media that inform us about the most outstanding events. Thanks to the news we can know which route to take towards our work, know when it is…
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The 505 (b) (2) application is one of three established types of regulatory submissions and may favor pharmaceutical sponsors. The FFDC defines the statutory submission of 505 (b) (2) as an NDA that includes a safety and efficacy investigation, most of which requires applicants to approve such an NDA. An applicant who is an applicant…
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Not all inputs or raw materials have the same importance, and depending on specific needs, each company may emphasize certain standards and not others. According to your needs it is must to have good Drug supplier selection. But in addition to this, having the right suppliers allows you to have certain control over production costs…
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The Food and Drug Administration (FDA) has several FDA drug labeling requirements and regulations that various industries must comply with. In June 2006, a new final FDA regulation, “Prescription Drug and Human Biological Product Content and Format Labeling Requirements,” came into effect. This rule is part of the FDA’s initiative to manage the risk of…
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During the development of a new drug, sponsors will show whether the product is safe for early human use and the pharmacologically and clinically relevant activity of the compound that requires further investigation for future commercial growth. If you need any help, the IND consultant will work with or play a role in the Chief Regulatory…
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