Even though the eCTD (Electronic Common Technical Document) format has been in existence for nearly ten years, now it has become a focal point for pharmaceutical, biologic and generic drugs manufacturers because of the US FDA (Food & Drug Authority) mandate stating that all NDAs (New Drug Application), BLAs (Biologics License Applications) and ANDAs (Abbreviated New Drug Applications) must be transitioned and submitted…
- April 4, 2017 Pharmaceuticals, Publishing & Submissions, Health Authority Updates
- March 28, 2017 Medical Devices, Publishing & Submissions
For the betterment of healthcare enabling the end user get ultimate benefits of safety and efficacy, there is always a reserved space for invention in the field of medical devices. With the technological development, medical device manufacturers are always on their toes to come up with the best possible innovative products. As the invention takes place, the need to better market them also grows.
- March 23, 2017 Medical Devices, Health Authority Updates
In a recent announcement, the Food and Drug Administration (FDA) has identified a broad list of Class II medical devices that, when finalized, will be exempted from premarket notification requirements, subject to certain limitations per se. The FDA has published this notice in accordance with procedures established by the 21st Century Cures Act, and is now looking forward to public response in the form of comments.
- March 21, 2017 Publishing & Submissions, Health Authority Updates
Ahead of nearing mandatory eCTD deadline, 5/5/2017, to clear the confusion surrounded, the Food and Drug Administration (FDA) of United States has clarified what exactly it is looking for in the Type III Drug Master File (DMF) submissions.
- March 14, 2017 Regulatory Medical Writing
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 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.