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Quality & Compliance
On April 26, 2023 the Commission adopted a proposal for a new Directive and a new Regulation which revise and replace the existing general pharmaceutical legislation under the following...
Clinical Research Solutions
Congratulations, FDA has approved your PMA! Now what? Securing a Premarket Approval (PMA) from the FDA is a significant achievement for any medical device manufacturer—a validation of your product's...
Quality & Compliance
Hello, fellow pharma enthusiasts! In the fast-paced world of pharmaceuticals, ensuring Good Manufacturing Practice (GMP) compliance is essential to maintaining product quality and safety. The...
Quality & Compliance
In the world of medical devices, particularly those categorized as moderate to high-risk, clinical data is a critical component of the regulatory approval process. This data, presented to regulatory...
Quality & Compliance
In the dynamic world of pharmaceuticals and biotechnology, small Sponsor companies are often the unsung heroes driving innovative therapies through the complex journey from concept to clinic. With...
Quality & Compliance
Hello, dear readers and fellow compliance enthusiasts! Welcome to our journey through the labyrinth of Good Manufacturing Practices (GMP) compliance. As a consulting company that provides audit...
Quality & Compliance
Importance of Quality Assurance in Clinical-Phase Drug Manufacturing Quality Assurance (QA) is a critical function in the pharmaceutical industry, ensuring that every aspect of drug manufacturing...
Regulatory Sciences
One of the big questions pharmaceutical, biotech and medical device companies often ask, is: “When is the optimal time to seek strategic regulatory consulting assistance?”. Traditionally, the need...
Medical Information
AI is a highly praised tool to implement across industries and service lines and Medical Information (MI) is no exception. In Medical Information, AI is embedded in a workflow for patients and...
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...
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...
Medical Information
Patient Support Programs (PSPs) in the pharmaceutical sector represent an array of aimed at supporting patients in initiating therapy and maintaining adherence. PSPs, also known as Patient Assistance...
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...
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
The link between statistical methods and healthcare is not a new one, but the volume of available data to inform healthcare decisions and the use of data science in the medical industry has exploded...