Profound research with poor documentation may not achieve Regulatory approvals. Documenting each section of ANDA demands attentive preparations by medical writers, else the entire development and marketing strategy will be derailed. Besides research protocols, the regulations, restrictions, and legalities that govern scientific and medical information play a vital role in ANDA submissions.
- May 25, 2021 Regulatory Medical Writing
- May 24, 2021 Medical Devices
It is a known fact that the European Union’s In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) will be in effect from May 26, 2022 and IVD manufacturers have to be prepared to implement the mandatory Regulatory requirements for this transition.
- May 24, 2021 Chemicals, Cosmetics Regulatory Services, Regulatory Affairs
The use of animal-derived constituents was pioneered at the beginning of the 18th century and slowly gained pace, soon after the advancement in science and technology. Earlier the application of animal-derived constituents was constrained to a few products such as leather products, colorants, cosmetics, etc.
- May 24, 2021 Medical Devices
Over the years, with the advancements of software and digitalization, there has been a seismic shift in how medical devices are administered and delivered. The integration of software with medical devices has rapidly increased and driving incredible advancements in delivering healthcare solutions across various domains like diagnosis, disease prevention and treatment of an injury or illness.
- May 21, 2021 Chemicals, Regulatory Affairs
Chemical Regulations in South Korea are managed by various Ministries such as the Ministry of Environment, Ministry of Employment and Labor, Ministry of Health and Welfare, Ministry of Agriculture, etc. under numerous laws based on the uses and hazard properties of chemical substances. The aim of all the Authorities is to protect human health and the environment from the toxicity of chemicals.
- May 20, 2021 Chemicals, Regulatory Affairs
The chemicals industry is one of Australia’s largest manufacturing sectors and a key enabler of almost every value chain. In Australia, chemicals are regulated under both territory/state and national laws. There are four (4) main Regulatory authorities for chemicals, and each authority focuses on a particular type of use.:
- May 19, 2021 Pharmaceuticals, Regulatory Labeling
The Therapeutic Goods Administration (TGA) of Australia has published guidance on TGO 91 and 92 on March 23, 2021 in order to assist sponsors and producers of medicines in complying with the Australian latest labeling standards.
- May 18, 2021 Chemicals, Regulatory Affairs
Risk Assessment of Chemical Substances in Canada is performed under the purview of Canada's Ministry of Health and the Ministry of the Environment. The risks posed by chemical substances are determined by the scientific evaluations or risk assessments conducted under the Canadian Environmental Protection Act, 1999 (CEPA 1999).
- May 17, 2021 Chemicals, Regulatory Affairs
The Chemical industry is the second-largest manufacturing industry in Japan. With increasing production and use the Chemical Regulatory Authorities of Japan aim to reduce exposure to hazardous chemicals and protect the health of the workers. One of the aspects of sound chemical management is the establishment and implementation of legal frameworks.
- May 13, 2021 Medical Devices
With the convergence of technologies and the connectivity of medical devices to various networks, there is an increased risk of cybersecurity exploitation, which affects the device’s operation. Hence, it is essential to have an effective medical device cybersecurity system to avoid cyber-attacks and ensure safe medical devices’ functioning.