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The Impact of Regulatory Sandboxes on Drug and Medical Device Innovation
Technology sandbox testing is revolutionizing the traditionally lengthy medical device approval process, cutting evaluation times by up...
Maureen May
Apr 22


Key Compliance Challenges in Cold Chain Logistics for Pharmaceuticals
Pharmaceutical cold chain logistics is a critical component of the healthcare supply chain, focusing on the safe and efficient...
Maureen May
Mar 6


Medical Device State Licensing: Stay Compliant and Avoid Disruptions
When it comes to the medical device industry, understanding state licensing requirements is crucial. Whether you are a manufacturer,...
Maureen May
Jan 23


Understanding Feasibility Studies and Testing in Pharmaceuticals
Nearly 90% of pharmaceutical projects fail to reach the market, resulting in billions of dollars in losses annually. Behind many...
Maureen May
Nov 27, 2024


Navigating Regulatory Changes in Specialty Drug Distribution
The pharmaceutical industry is witnessing a significant shift in drug distribution, with specialty distribution taking center stage. This...
Maureen May
Oct 23, 2024


Quality Assurance vs Quality Control: Key Differences in Pharma
In the pharmaceutical industry, ensuring product quality and safety is paramount. Quality assurance and quality control play crucial...
Maureen May
Sep 17, 2024


Benefits and Implementation of eQMS in the Pharma Industry
The pharmaceutical industry faces a myriad of challenges in today's dynamic landscape - from evolving regulatory requirements and complex...
Maureen May
Aug 2, 2024


Essential Elements of Pharmaceutical Quality Management Systems
The pharmaceutical industry is subject to stringent regulations and quality standards to ensure the safety, efficacy, and purity of drugs...
Maureen May
Jul 3, 2024


Understanding FDA Medical Device Classes & Their Distinctions
Medical devices play a crucial role in the modern healthcare landscape. These technologies have transformed the way healthcare...
Maureen May
Jun 10, 2024


A Guide to Over-The-Counter (OTC) Drug Monographs & Recent Updates
Understanding the complex landscape of Over-the-Counter (OTC) drug monographs is a critical aspect of the regulation of nonprescription...
Maureen May
May 18, 2024


What You Need to Know About cGMP in Pharma
The pharmaceutical industry plays a critical role in ensuring the health and well-being of individuals around the world. To maintain the...
Maureen May
Apr 2, 2024


The Role of Patents in Medical Technology Licensing
In the rapidly advancing field of healthcare, medical technology has ushered in a new era, empowering healthcare providers and patients...
Maureen May
Mar 20, 2024


State Drug Licensing for Virtual Manufacturers
In the pharmaceutical industry, drug licensing is a critical aspect of ensuring compliance with regulatory requirements. This is...
Maureen May
Mar 1, 2024


The OTC Application Process for Non-Prescription Drugs
Introduction The significance of nonprescription drugs cannot be overstated in today's fast-paced world. These over-the-counter (OTC)...
Maureen May
Feb 9, 2024


Biotech vs Pharma: Understanding the Distinctions & Nuances
Introduction The pharmaceutical industry is a dynamic and ever-evolving field that plays a crucial role in advancing healthcare and...
Maureen May
Dec 19, 2023


Registration & Licensing for Foreign Device Manufacturers
The medical device industry is witnessing rapid growth, and with it comes the need for foreign manufacturers to navigate the complex...
Maureen May
Nov 10, 2023


Medical Device Licensing for 3PLs: Guide for 3PL Compliance
In the rapidly evolving healthcare industry, the efficient management of the supply chain is crucial for the safe and timely delivery of...
Maureen May
Oct 8, 2023


Understanding the Distribution of Medical Devices
In the highly regulated and competitive medical device industry, effective distribution plays a crucial role in the success of device...
Maureen May
Sep 7, 2023


A Guide to Pharma 3PLs & Third Party Logistics Providers
In an increasingly complex and competitive business landscape, pharmaceutical companies are constantly seeking new ways to optimize their...
Maureen May
Aug 30, 2023


Drug Product Manufacturers: Don't risk supply chain disruptions by overlooking state drug licensing
For companies engaged in the drug and medical device supply chain, there’s no shortage of requirements to get their products to market....
Maureen May
May 10, 2023
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