Start Up and Generic Pharmaceutical Drug and Biologic Companies have high quality, affordable products that improve the quality of life for their patients. However, this often is associated with austere conditions wherein time and funds are both in short supply. Effective use of Real World Data (RWD) and Real World Evidence (RWE) can reduce costs…
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…