Preparing premarket submissions that win regulatory approval

Preparing premarket submissions that win regulatory approval is a complex task, even for the most seasoned professional in the medical devices industry. This is because of the highly stringent nature of the regulatory approval pathways, namely the Premarket Approval (PMA) process and FDA regulatory 510(k) clearance. What makes preparing premarket submissions that win regulatory approval […]

Management systems should be expansive and versatile

Management systems should be expansive and versatile, as having such a system makes sense for organizations. A management system is a mechanism that helps streamline an organization’s day to day functioning without hassles. It should put the organization on the path it chooses to take by putting in place a set of documents that is […]

HIPAA survival needs intimate knowledge of the nuances of the law

HIPAA survival is one of the great challenges for a healthcare entity. HIPAA audits are complex, and they need understanding of the jargon and the semantics of the words mentioned in the document to survive. Both the Covered Entity and the Business Associate need to know exactly what to do in order to pass a […]

Dealing with medical device reporting and recalls

Medical device reporting and recalls have enormous benefits for the medical device company and the public if implemented properly. They can prevent use of defective devices and can be an important inoculation against stringent FDA actions. Medical device reporting and recalls are a major FDA activity. Medical device companies have clear instructions on how to […]

GMP Compliance for Pharmaceutical Laboratories

In order to ensure GMP compliance, pharmaceutical laboratories have to devise a holistic and long term plan that covers all aspects of the laboratory’s activities. Good Manufacturing Practices (GMP) requirements for laboratories have been set out by various regulatory bodies. The aim of GMP compliance for a pharmaceutical laboratory is to ensure that Products must […]

Application of concepts and theories of clinical research

Protection of human subjects and everything relating to it is of paramount importance for those involved in or wanting to be involved in research dealing with human subjects or an individual’s private identifiable information. For these individuals, professionals and companies, it is extremely important to understand that there are federal regulations that must be followed. […]

Application of concepts and theories of clinical research

Protection of human subjects and everything relating to it is of paramount importance for those involved in or wanting to be involved in research dealing with human subjects or an individual’s private identifiable information. For these individuals, professionals and companies, it is extremely important to understand that there are federal regulations that must be followed. […]

Preclinical Toxicology & Safety and its core elements

Preclinical toxicology and safety occupies a position of eminence in a clinical research program. A study of preclinical toxicology and safety is absolutely important because this leads researchers to an understanding of what causes adverse effects. Adverse effects form the backbone of preclinical toxicology and safety, because they can come from any source of toxicology. […]

A very brief overview of Post marketing Safety Management

Post marketing Safety Management is a very important area of a Good Clinical Practice (GCP) and Good Vigilance Practice (GVP). This is why the FDA has very detailed and clearly laid out requirements that organizations and sponsors of clinical research have to comply with as part of meeting safety requirements. The FDA’s requirements on post […]

Orphan Drugs in the USA

Orphan drugs are drugs that are exclusively developed and used for treating rare diseases. Orphan drugs are not researched and developed for widespread use, since by their nature, they are meant only for rare diseases. Since by definition, a rare disease is not likely to have too many patients; orphan drugs are limited in their […]