Regulatory compliance consultants contribute to healthcare organizations in attaining conformance with government rules. They characteristically advise senior management and help grow processes and programs to safeguard organization-wide obedience with appropriate laws and standards.

More about FDA consultants:

FDA compliance consultant service enables the person to quickly get the products to market to maintain the FDA compliance status. An FDA compliance can help companies to…

Clinical research refers to the field of science, which can be used in determining the safety and efficacy of healthcare products. This kind of research is beneficial in the relief, treatment, and prevention of various diseases. Good clinical practices allows for the best interpretation of results to establish procedures in the best use of products to be brought to market. The manner in which the clinical research is performed is important to regulatory bodies across the globe.

The…

Having a wish for good health is a choice for all living-being, but God does not grant this blessing attribute to everyone. These days, the medical industry brings a lot of change in one’s life, and expectation for life expectancy rate increases fairly well. While feeling sick, it is obvious to take the medical consultation to come back in betterment through checkup with the medical device. For getting a clear assessment of disease, operating equipment must have the…

505(b)(2) - The New Regulatory Pathway for NDA

What is 505(b)(2)?

To properly understand the meaning of 505(b)(2), we first need to understand the concept of a New Drug Application (NDA). NDA, in simple terms, means an application that has been proposed by a drug developer in front of the FDA (Food and Drug Administration) in the US for getting approval to sell the new drug in the market. After getting the permission, the applicant is authorized to sell it to the public. To…

FDA's Drug Registration

Drug discovery is the process of discovering a new molecule and bringing it to the sector or public. Discovering a new molecule is a lengthy process, expensive, and certainly will be accomplished by pharmaceutical companies. Out of several thousands of new compounds, just a few will be considered for testing in people, and among those few, only one, i.e., the final product, will be approved and marketed. Drugs directly act on goal websites that are accountable…

First, PDG will help you determine if an IND is required. FDA Guidance notes that there are times when it may not be clear if use of an FDA-regulated product might trigger an IND filing. However, FDA does not charge sponsors for Pre-IND meetings. PDG has orchestrated early stage strategies and Pre-IND Meetings for a variety of submissions including new clinical uses of a marketed drugs (new indications), new formulations and fixed dose combination products. Moreover, PDG has had success in…

The Food and Drug Administration (FDA) administers inspections and assessments are the regulated facilities used to determine a company's obedience with all the applicable laws and regulations, which are used in industries such as the Food, Drug, and Cosmetic Act and other related Acts.

It's significance

FDA facility inspection normally discloses a large number of inspection information to the public to…

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 effective to use only when they are prescribed by a doctor. However Non-prescription drugs are those which can be…

The abbreviated form of FDA is food and drug administration. It is a US health information organization. The FDA is involved in the medical devices field, but its main purpose is to defend humans alongside injury from possibly dangerous medications and food. It also provides as a safety reporting agency where whistle-blowers can report health safety worries and outcomes secretly. It also oversees the department of biological products such as vaccines, which treat allergies and cosmetics. FDA…

Earlier, companies could make claims about a product without proof that it was safe. This made consumers extremely vulnerable. Currently, new products must go through the FDA approval process before they are available to the public. The US Food and Drug Administration examines, evaluates and approves a wide range of products for medical use, including drugs, medical devices, foods, cosmetics and many other health-related products.

What is the process for approval?

For a drug or…

The FDA published the guidance document Medical Device Submission Feedback and Meeting Requests: Q Submission Program in 2019, but it took the industry to understand all aspects of the program. This guidance covers a wide range of FDA submissions, including IDE / PMA / HDR applications, de novo requests, 510 (k) submissions, and CLIA exemptions. Given this wide range, it is useful to look at the various options in the Q-Sub program.

Type of Q submission

Let’s understand the…

Toxicology is the study of substances that harm living organisms, either at the cellular or molecular level. From a functional point of view, this discipline can be divided into clinical, environmental, occupational and forensic toxicology. Clinical toxicology focuses on damage caused by acute or chronic exposure to excessive concentrations of a substance.

What is a toxicological study?

A toxicological study is the search of the possible etiological agents that cause a clinical…