200+ followers. WOWWWWWW…

Hello Everyone, Today we have the pleasure of celebrating the fact that we have reached the milestone of 200+ followers on WordPress. Since we started this blog, we have had such a great time connecting with everyone.  we never expected to actually to connect with other people in the blogging community. we are so incredibly […]

Seminar Calendar of Upcoming Courses – June to July – 2017

seminars are a wonderful opportunity for professionals in the regulatory compliance

Validation in accordance with ICH guidelines

Professionals in the field of statistical analysis need a clear and perceptive insight into how to understand and interpret statistical concepts used to investigate quantitative ICH Guidelines such as analytical methods validation, procedures and acceptance criteria in calibration limits. Along with these, process and quality controls, as well as ICH Q8 and Q9 also need […]

Good Manufacturing Practices are essential for ensuring quality

Key Takeaway: GMPs are critical for the manufacture and distribution of foods, drugs and other pharmaceutical products. These need to be implemented diligently by organizations that are involved in these products. Quality is a great concern for a manufacturer and consumer of any product. To ensure that quality is maintained across a variety of products […]

Tips and Suggestions on interacting with FDA Officials and Premarket Approval (PMA)

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 […]