Vineed is an IT sales professional with over a decade of software solutions experience. He manages enterprise pharmaceutical and medical device manufacturers accounts that are located on or near the North American West Coast. He has also mastered 6 languages: Kannada, Tamil, Malayalam, Hindi, Telugu and English.
Navigating FDA Guidelines for Pharmaceutical Packaging: A Focus on Packaging Artwork
Pharmaceutical packaging plays a critical role in ensuring the safety, efficacy, and quality of medications. The US Food and Drug Administration (FDA) closely regulates packaging and labeling, as well as manufacturing processes in pharmaceutical packaging. Ultimately, these regulations and guidelines safeguard patient health.
Health Canada’s XML Product Monograph Update: What It Means for Regulatory Teams
Health Canada has announced changes to the filing requirements for Extensible Markup Language (XML) Product Monographs (PMs), signaling a shift toward enhanced digital documentation standards. The first phase of these requirements come into effect on July 18, 2025. These updates will impact regulatory teams, requiring adjustments in their processes to meet the new expectations.
Avalis Publishing Case Study – Compliance through Watertight Version Control
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 to small and mid-sized companies. The focus of its activities is on submissions to the US Food and Drug Administration (FDA). The company deals with documents ranging from pre-Investigational New Drug Application (pre-IND stage through to post-marketing support, such as promotional materials, labeling, annual reporting and supplemental applications. Compliance, document integrity and a watertight version control process underpin all its publishing activities. Version control is a key factor as the two business partners deal with a large number of document updates and changes. Many of its clients do not have direct expertise in publishing the required regulatory documents. A brief encounter with the “sleeping rabbit” The business relationship between Avalis Publishing and Schlafender Hase dates back some seven years to an industry event in which Schlafender Hase was participating as a vendor. While strolling through the vendor hall, the two business partners noticed the unusual “sleeping rabbit” logo and, intrigued, approached to investigate. Discussion ensued and the company decided to trial TVT, the Text Verification Tool from Schlafender Hase. This marked an initial step away from manual proofreading. Alison Moraska explains: “Especially with our larger documents and labeling, we needed to do time-consuming checks line-by-line, paragraph-for-paragraph, often with someone else doing an additional check. Manual proofreading was not perfect, as we’re all human, and it costs a lot of time.” The partners at Avalis Publishing immediately recognized the advantages of verifying versions using TVT, and purchased a license. “Many software vendors are geared primarily to larger companies, whereas we recognized that the solution from Schlafender Hase was also applicable to us as a small company. It’s important to be able to trust the software we use,” Alison Moraska adds, “and we know we can trust TVT.” Ms Moraska points out that the company deals with many amendments and last-minute changes. Furthermore, there are cases when a client will deliver documents in two versions – one in track change and the other in integrated clean copy. By running the documents through TVT, she can immediately see any discrepancies between versions and inform the customer. Additionally, when transferring content from customers into clean templates, TVT is especially important for providing certainty that content transfer is complete and identical to the original source file. This extra level of thoroughness in version control leads to greater document integrity, higher quality of service and client trust. TVT promotes efficiency and compliance The portfolios of clients who turn to Avalis Publishing are growing, and the time saved through document comparison software translates into capacity to manage higher workloads and more time to focus on other tasks at hand. Gone is the doubt that, through manual processes, document version issues might arise. Another outcome has been that that TVT can be used effectively as a “diagnostic tool” in the publishing process. “After running a comparison, I immediately know the extent of changes
The Critical Impact of Labeling Errors in the Pharmaceutical Industry
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.
The Ripple Effect: Exploring the Extensive Costs Associated with Product Recalls
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?
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.
5 Ways a Proofreading Software will Keep your Regulatory Affairs Team Happy
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.
Azurity Pharmaceuticals Case Study – Effortless Comparison in Labeling and Promotional Review
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.
New World Medical Case Study – Saving Resources and Increased Efficiency for Proofreaders
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.
Speed to market is king in the fast-moving world of consumer goods. Yet, countless hours are spent reviewing packaging artwork before going to market. Traditional review methods are time-consuming and prone to human error. A single mistake in an ingredient list or a barcode could result in lost sales or shelf space, a recall and damage to the brand reputation.
Speed to market is king in the fast-moving world of consumer goods. Yet, countless hours are spent reviewing packaging artwork before going to market. Traditional review methods are time-consuming and prone to human error. A single mistake in an ingredient list or a barcode could result in lost sales or shelf space, a recall and damage to the brand reputation.
Navigating FDA Guidelines for Pharmaceutical Packaging: A Focus on Packaging Artwork
Pharmaceutical packaging plays a critical role in ensuring the safety, efficacy, and quality of medications. The US Food and Drug Administration (FDA) closely regulates packaging and labeling, as well as manufacturing processes in pharmaceutical packaging. Ultimately, these regulations and guidelines safeguard patient health.
Navigating FDA Guidelines for Pharmaceutical Packaging: A Focus on Packaging Artwork
Pharmaceutical packaging plays a critical role in ensuring the safety, efficacy, and quality of medications. The US Food and Drug Administration (FDA) closely regulates packaging and labeling, as well as manufacturing processes in pharmaceutical packaging. Ultimately, these regulations and guidelines safeguard patient health.
Top Regulatory Challenges in Food Labeling and How to Overcome Them
Food labeling plays a crucial role in protecting consumer health by providing information relating to food sources, nutrition and safety. Accurate and informative food labeling allows consumers to make informed dietary choices. Compliance with food labeling regulations is not only a legal requirement but also impacts brand reputation.
Top Regulatory Challenges in Food Labeling and How to Overcome Them
Food labeling plays a crucial role in protecting consumer health by providing information relating to food sources, nutrition and safety. Accurate and informative food labeling allows consumers to make informed dietary choices. Compliance with food labeling regulations is not only a legal requirement but also impacts brand reputation.
