Medical Writing industry is on an upward surge, mainly driven by an increasing demand in Emerging markets to have high-quality documents authored to support timely drug approvals. At the face of the demand, more than the perfection in the domain, organizations should focus on obtaining clarity on what exactly is medical writing than being confused with science writing. How both the aspects differ?
- March 14, 2017 Regulatory Medical Writing
- March 2, 2017 Regulatory Intelligence, Regulatory Consulting
Wading through uncharted waters is always risky and mount numerous pressures on organizations. It not only affects organization’s financial status quo but also impose threat to brand image. If it is the same in the life sciences sector, the situation may lead to incompliance and untimely drug approvals thus posing a threat to patient safety.
- February 28, 2017 Publishing & Submissions, Health Authority Updates
As we all are aware, the United States Food and Drug Administration’s (US FDA’s) electronic Common Technical Document (eCTD) requirement is nearing the deadline.
- February 24, 2017 Cosmetics Regulatory Services
Are you a cosmetic product manufacturer looking to obtain market authorizations across the European Union? Do you know what consists of your mandatory technical documentation need to be submitted for cosmetic products’ market approvals?
- February 15, 2017 Regulatory Labeling
Managing product information is quite a task. In the stringent world of life sciences, to do so, manufacturers must follow certain standards and procedures which are aligned to FDA’s regulations. Not only do they have to follow the set procedures but they are also required to maintain accuracy and integrity of information to be prescribed for an end-to-end compliance.
- February 10, 2017 Regulatory Artwork Services
With years of time spent on innovating new drugs, life sciences organizations, sometimes, take a backseat to allocate sufficient time for artwork design processes that result in inaccurate and incompliant marketing of products followed by product recalls affecting the overall costs. With defined Regulatory artwork processes, organizations can sustain critical situations like these especially in time-bound pressures.
- February 7, 2017 Pharmaceuticals, Regulatory Artwork Services
Even when artwork packaging is often considered to be a seemingly insignificant back office job, Artwork Pack Management is one of the key processes in the stringently regulated pharma world. For any given pharmaceutical or life sciences company, meeting the ever-changing regulatory-driven requirements of global markets and finding cost-effective ways to stick to compliance standards is a constant challenge.
- February 3, 2017 Publishing & Submissions, Health Authority Updates
What does it mean for Drug Approval Processes?
- January 31, 2017 Pharmaceuticals, Medical Devices, Regulatory Artwork Services
With years of efforts put into new drug, device and cosmetic products’ development, what can be every manufacturer’s nightmare would be to see their product recalled from the market for incompliant artwork issues. According to a study, it is estimated that 35 to 40% of product recalls are attributed to mislabeling and packaging errors.
- January 24, 2017 Regulatory Intelligence, Regulatory Consulting, Health Authority Updates
In a recent announcement, the US Food and Drug Administration (FDA) asserted the ban on powdered medical gloves will come into effect, beginning 19 January 2017.