Clinical and nonclinical research programs demand the development of high-quality documents for timely submissions and approval of the drug product from Regulatory authorities. Medical writing plays a crucial role in drafting all the necessary documents right from drug development through submission and approval.
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January 19, 2021 Regulatory Affairs, Regulatory Medical Writing -
January 5, 2021 Medical Devices, Regulatory AffairsThe US FDA continues to release and update the guidelines and enforcement policies for efficient management of the device Regulatory affairs in the USA, alongside handling the emergency health situation that surfaced due to the COVID-19 pandemic.
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January 5, 2021 Medical Devices, Regulatory AffairsThe MDCG (Medical Device Coordination Group) has released a position paper on UDI assignment to assist the manufacturers of spectacle lenses and ready readers about the obligations under the EU Medical Device Regulations (EU MDR) 2017/745. It also has the details to be considered while assigning an UDI (Unique Device Identification) to these devices.
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December 21, 2020 Medical DevicesBuilding and managing an efficient Quality Management System (QMS) is a crucial step for medical device enterprises willing to deliver the right product to the customers. As almost all major markets across the globe made it a thumb rule to go by a compliant QMS while registering the products, it is indeed a primary requirement for manufacturers to maintain QMS for a successful product launch...
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December 21, 2020 Chemicals, Cosmetics Regulatory Services, Regulatory AffairsChemical products are used in a variety of sectors in the Life sciences industry. Pharmaceuticals and cosmetics sectors are a few among them.
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December 9, 2020Ministry of Ecology and Environment (MEE) of China published the revised law for new chemical substances on May 7, 2020, which is said to be replacing the existing legislation, MEP Order 7, from Jan 1, 2021. The new update focuses on the major changes that MEE Order 12 has introduced and their implications for the industry from a legal standpoint. Let us have a brief look at it.
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December 9, 2020 Medical Devices, Regulatory Affairs, Regulatory Labelinge-labeling plays a critical role in the medical devices industry, as it ensures to improve operational efficiency, maintain brand consistency, obtain compliance and support business growth. Hence, the device industry is moving towards adopting end-to-end e-labeling life cycle procedures, starting from label content creation to review and approvals.
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Medical Face Masks and Particulate Respirators - Decode SFDA’s Requirements and Recognized Standards
December 9, 2020 Medical Devices, Regulatory AffairsAs it is well known, Medical masks to be launched in the Kingdom of Saudi Arabia (KSA), must obtain Medical Devices Marketing Authorization (MDMA). In reference to the same, the Saudi Food and Drug Authority(SFDA) has recently released a guidance to specify and clarify the requirements and recognized standards to streamline products’ market-entry.
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December 3, 2020 Cosmetics Regulatory Services, Regulatory AffairsImported Cosmetic products are regulated in India under the provisions of the Drugs & Cosmetic Act 1940 & Rules 1945. For importing Cosmetics in India, the products are required to be registered with the Central Drugs Standards Control Organization (CDSCO) by giving an application in Form 42 to obtain the Registration certificate in Form 43.
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November 23, 2020 Chemicals, Regulatory AffairsMany countries are adopting, ban on animal testing, globally. Walking the same path, Brazil too has taken early steps towards the cause, but with many changes all through.