Introduction: Devices exempted under 510(k) state if the device offers safety and is highly effective on the consumers under the FDA. Exempted Devices which get relaxation by 510(k) are classified by the FDA into Class I type, Class II type, and Class III type. There are specific regulations mentioned with each generic type of device.…
Formulation chemistry is the systematic and step-by-step approach to pharmaceutical development. Nowadays, as the usage of medicines is increasing, pharmaceutical companies are more eager to bring manufacturing a new look in quality and performance. It involves designing, analyzing, and controlling manufacturing by taking timely measurements to ensure final product quality, efficacy, and safety. Pharmaceutical Product…
Introduction Food and Drug Administration is a government entity in the United States whose objective is to protect the public by verifying that nutritional supplements are safe to use and accurately labelled. Businesses can even use the FDA Pre-submission to get feedback on possible and planned medical advice, biologics and medication submission. It’s a fantastic…
Introduction FDA (can also be expanded as the Food and Drug Administration) is a bureau that administers the public’s welfare by controlling and surveillance of food products, medications, vaccines, medical devices, etc. There are certain rules and criteria for post marketing safety reporting of FDA combination products. What are combination products? As per FDA’s guidelines,…
After the FDA 510 k submissions, there is a lengthy review process there that is being performed by the team. Also, getting the certification is not a very easy task. For this reason, a brief checklist is here that are needed to be considered so that the submission and certification procedure will get more hassle-free.…
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…
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…
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…
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…
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,…
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…
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…
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…
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…
The Food and Drug Administration (FDA) in the US requires that all Dietary Supplements be regulated by the Dietary Supplements Health and Education Act of 1994. Manufacturers of the product must ensure that they make sure your products are safe and accurately labeled. The FDA can take action against any manufacturer selling a product that…
In the U.S., every drug producer and manufacturer have to register in the FDA (FOOD AND DRUG ADMINISTRATION) before selling it to the market; we term this as Establishment Registration in FDA. Registration in the FDA means the FDA is aware of the medicines, medical devices, drugs, and other related product consumption by its people…
Although all countries have a different regulatory procedure for new drug approval and market a particular drug worldwide, the drug has to pass through the Marketing Authorization Application (MAA) of different countries. As USA plays an essential role worldwide in distribution and marketing drugs, one should know NDA Regulatory Services and its rules in USA.…
Introduction Post marketing surveillance of drugs is an important part of the FDA. Whenever a drug is released in the market, it has to be monitored to see how people are doing after taking the drug. This helps keep them regulated safely, and they also provide further studies. These studies give further insight into how…
Non-prescription drugs are commonly known as over the counter medicines (OTC). These drugs can be bought from a retailer without any prescription. FDA decides which treatments need a prescription and which can be purchased over the counter. Now let’s see the difference between prescription and non-prescription drugs. Prescription medicines are those which are safe and…
Introduction: Devices exempted under 510(k) state if the device offers safety and is highly effective on the consumers under the FDA. Exempted Devices which get relaxation by 510(k) are classified by the FDA into Class I type, Class II type, and Class III type. There are specific regulations mentioned with each generic type of device.…
Formulation chemistry is the systematic and step-by-step approach to pharmaceutical development. Nowadays, as the usage of medicines is increasing, pharmaceutical companies are more eager to bring manufacturing a new look in quality and performance. It involves designing, analyzing, and controlling manufacturing by taking timely measurements to ensure final product quality, efficacy, and safety. Pharmaceutical Product…
Introduction Food and Drug Administration is a government entity in the United States whose objective is to protect the public by verifying that nutritional supplements are safe to use and accurately labelled. Businesses can even use the FDA Pre-submission to get feedback on possible and planned medical advice, biologics and medication submission. It’s a fantastic…
Introduction FDA (can also be expanded as the Food and Drug Administration) is a bureau that administers the public’s welfare by controlling and surveillance of food products, medications, vaccines, medical devices, etc. There are certain rules and criteria for post marketing safety reporting of FDA combination products. What are combination products? As per FDA’s guidelines,…
After the FDA 510 k submissions, there is a lengthy review process there that is being performed by the team. Also, getting the certification is not a very easy task. For this reason, a brief checklist is here that are needed to be considered so that the submission and certification procedure will get more hassle-free.…
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…
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…
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…
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…
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,…
