Avalis Publishing, a business partnership built around Lisa Johnson and Alison Moraska, provides electronic Common Technical Document (eCTD) submission and other electronic regulatory publishing expertise
In the complex landscape of pharmaceutical manufacturing, every detail matters. From the formulation of the drug to its packaging and labeling, precision is vital. However, despite stringent regulations and quality control measures, labeling errors persist, posing significant risks to patient safety and public health.
It takes endurance and the tools of skilled professionals to advance a new product from R&D through to market. The investment is enormous, and the competition is breathing down the innovator’s neck. Can you afford the costs of a recall or product delay?
Counterfeit medical products, including drugs and devices, pose a serious global threat to public health.
Navigating complex labeling requirements for medical devices. Your guide to the fundamentals of regulation and compliance and how automated proofreading can minimize your labeling risks.
Proofreading documents manually in regulatory affairs (RA) in the life sciences industry is stressful, high-risk and can lead to job dissatisfaction. The stakes are high – errors can harm patient health, result in product recalls, and damage brand and company reputations. Here’s how TVT, the proofreading software for regulatory affairs, can keep an RA team happy.
Following an increase in the number of products after an acquisition, the labeling team at Azurity Pharmaceuticals encountered new challenges in their proofreading process. TVT was their chosen regulatory proofreading software.
With implementation of TVT in its quality assurance department, New World Medical is achieving significant time savings. It now also plans to roll out the automated proofreading solution from Schlafender Hase across other parts of the company.
Curious about the history of pharmaceutical recalls and the billions of dollars lost? Please see below for 10 pricey issues and the health risks associated behind the reason for the recalls.
