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Quality & Compliance
Compounding is a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes,...
Clinical Research Solutions
In case you haven’t noticed, FDA is tired of being the “bad guy”. While they do not back-off of their responsibility to enforce the applicable Code of Federal Regulations for a millisecond, their...
Clinical Research Solutions
So far in our series on GAMP 5 we’ve provided a high level overview of the five major GAMP concepts, and a more in depth discussion of Concept 1, Process Knowledge and Understanding. In this...
Clinical Research Solutions
Today, more pharmaceutical companies are turning to outsourcing their products as a strategic part of their business model. There are a number of drivers for this shift to soliciting the services of...
Clinical Research Solutions
When it comes to the Healthcare industry (e.g. pharmaceuticals, medical devices, dietary supplements, etc.) who owns a company's Quality Assurance practices? Without a doubt the Quality organization...
Clinical Research Solutions
Expanding an existing lab or establishing a new lab is an exciting time; new equipment, new facility, a fresh start. The key to having a successful laboratory qualification project is communication...
Clinical Research Solutions
Ever wonder why some—most—projects don’t go as planned? Let me take a chance at explaining what I have observed in the last few decades. Firstly, let us assume that you have contracted a well-known...
Clinical Research Solutions
As a biopharmaceutical company matures and new products are added to its portfolio, expansion of its facilities, systems and Quality Control is a natural outcome. The growth in the Quality Control...
Clinical Research Solutions
In my previous blog I re-visited key GAMP® 5 concepts as they relate to establishing a compliant system validation methodology. My next few blogs will focus on each of these concepts in more detail....
Clinical Research Solutions
In order to incentivize the development of therapies (drugs biologics) to fill unmet medical needs for treatment of serious conditions, the FDA has developed various programs to expedite drug...
Clinical Research Solutions
Part 1 of this series discussed confidence intervals. Confidence intervals are the best known of the statistical intervals but they only bound regions associated with population parameters; i.e., the...
Regulatory Sciences
Compiling and submitting a New Drug Application (NDA) submission is a complicated and intensive activity. Once you have submitted your application to FDA, you may be curious about what can you expect...
Medical Information
Patient Support Programs (PSPs) in the pharmaceutical sector offer a range of services to help patients start and adhere to their therapies, including Patient Assistance Programs (PAPs), patient...
Regulatory Sciences
This article has been updated since its original February 28, 2017 publication. Since the introduction of the Prescription Drug User Fee Act (PDUFA) VII for fiscal years 2023 - 2027, the FDA...
Clinical Research Solutions
What is a Clinical Study Report? A Clinical Study Report (CSR) is a document that describes the methods and results of a clinical study or trial, along with a short discussion of key findings related...