The Conformity Assessment Body (CAB) plays a vital role in issuing various certifications and carrying out technical assessments required for successful registration and distribution of your medical devices and IVDs.
- June 10, 2021 Medical Devices
- June 3, 2021 Cosmetics Regulatory Services, Regulatory Affairs, Regulatory Labeling
Labeling and packaging are the two (2) important stages in the product lifecycle. They allow the consumers to know more about the product and understand its appropriate usage. From a manufacturer’s point of view, correct labeling helps in achieving compliance with the Regulatory bodies, defining the quality and providing statutory warnings to consumers.
- May 25, 2021 Regulatory Medical Writing
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 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).