Fragrances are a combination of chemicals that render a pleasant scent to perfumes and colognes. Cosmetics and personal care products like makeup products, moisturizers, and shampoos contain fragrances. An attractive fragrance makes the product more appealing to the consumer and enhances the user experience. Fragrances also influence buying behavior and give a competitive edge to the product.
- December 3, 2021 Cosmetics Regulatory Services, Regulatory Affairs
- November 29, 2021 Medical Devices
With the evolution of technology, the healthcare industry has become keen on integrating software with medical devices to incorporate automation and accuracy in the prediction, diagnosis, prevention, treatment, and management of health conditions.
- November 18, 2021 Medical Devices
Design of logical Instructions for Use (IFU) and Operation Manual of medical devices requires an efficient, structured, and organized approach. It is critical for ensuring a medical device user’s safety and comprehension, as IFU and manuals are used to inform the end-user how to use the device.
- November 18, 2021 Medical Devices
Medical device industry ensures that users can use medical devices safely, effectively, and efficiently.. Creating Instructions for Use (IFU) for medical devices requires quite a lot of responsibility. It requires a combination of technical communication skills with project management, administrative and legal skills.
- November 16, 2021 Pharmaceuticals, Regulatory Affairs, Health Authority Updates
Since 2007, Product-Specific-Guidances (PSGs) have provided the pharmaceutical industry recommendations for manufacturing generic medicinal/drug products.
- November 15, 2021 Medical Devices
As we all know, the FDA will first evaluate the potential risk of a medical device before it is launched in the USA. The evaluation is done through a risk-based classification process to ensure the device’s safety, quality, and efficacy. The low-risk Class I devices require only general controls, and the high-risk Class II devices are subject to special controls and require more Regulatory scrutiny and oversight.
- November 12, 2021 Pharmaceuticals, Regulatory Affairs
The need for life-saving drugs is on a constant rise. Owing to novel diseases proving fatal, drug manufacturers are spending a lot of time and money on the research and development of chemical and biological drugs. As challenging as inventing Innovator drugs is, it can be equally daunting for manufacturers to register them.
- November 11, 2021 Medical Devices
As we all know, there are continuous updates to the existing technologies alongside the advent of new ones. Incorporating these technologies into the drug-device combination products for tracking and monitoring purposes is increasing day by day.
- November 10, 2021 Medical and Scientific Communication, Regulatory Medical Writing
Communication through digital media vastly influences the perception of consumers regarding a product/service. Hence, pharmaceutical firms are constantly evolving to achieve a fair balance while advertising their products. Regulators, on the other hand, monitor the quality and authenticity of the data being published.
- November 10, 2021 Chemicals, Regulatory Affairs
Recently, the U.S. Environmental Protection Agency (EPA) revised the Lead and Copper Rule (LCR) to protect children and communities from the risks of lead exposure. EPA aims to get the lead out of the drinking water and empower communities through the correct information. According to the recent revision, the new rules includes the following improvements: