QuVa Pharma, a leading national 503B outsourced sterile compounding company, has a broad portfolio of ready-to-administer products that hospitals and health systems rely on to ensure high quality...
Visualizing a new data-centered quality paradigm. When the first Nokia and Motorola cell phones that were affordable and small enough to fit in your pocket hit the market...
WD-40 Company needed a way to ensure that every drop of product produced by globally diverse contract manufacturing organizations (CMOs) measured up to the company’s unwavering standard of quality.
While already overseeing the world’s second-largest pharmaceutical market, China’s State Administration for Market Supervision is working to bring international drugs into the Chinese market faster.
Every organization engaged in a clinical trial must manage and maintain all trial-related content, documents, and data in a manner that supports the claims to the safety and efficacy of a product.
The U.S. Food and Drug Administration has released data on the most common observations it makes during inspections of pharmaceutical facilities. This white paper explores the top 10 deficiences.
The ICH Q10 Guideline 'pharmaceutical quality systems' was signed off as a Step 4 document at the ICH meeting in Portland, Oregon, in June 2008.
This white paper shares 12 tips for a successful eCTD submission based on a presentation by an FDA official.
This white paper discusses six areas senior management tend to overlook, from proper investment in CROs to personnel training, and what the implications are in terms of compliance.
Identify strategic ways that software solutions and automation can support overall efforts to secure external resources, from funding of research studies to establishing licensing deals.
Pharmaceutical companies stand to experience significant operational advantages by transitioning to automated, electronic processes instead of continuing to use manual paper-based or hybrid systems.
MasterControl offers this collection of resources to help pharma manufacturers on their path to paperless.
MasterControl Registrations for eCTD is a cloud-based solution designed to streamline content generation and the collection and management of artifacts required for regulatory submission.
This FDA Readiness Toolkit is designed to help pharmaceutical companies simplify compliance with FDA standards and streamline quality processes.