Brazil is the largest cosmetic market in the Latin American region. Increasing consumer awareness and a rising disposable income ensure steady market growth. Major international cosmetic brands also have a presence in this attractive market.
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August 30, 2021 Cosmetics Regulatory Services, Regulatory Affairs -
May 12, 2021 Medical DevicesWith the advent of digitization, many global organizations, especially in life sciences and med-tech industries, have randomly shifted their data from paper to digital forms. Thanks to the stringent regulations, like US FDA’s 21 CFR Part 11 (21 CFR 11) regulation, the digitalized data forms are coming out to be accurate, efficient, productive, quality-oriented and reliable.
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April 1, 2021 Food and Food SupplementsWe all are aware of how food and medicine are different in terms of how they individually nourish the body, but both eventually tend to mainly assist in maintaining our health.
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February 16, 2021 Medical DevicesThe medical devices industry is considered as highly regulated. Hence, devising a right Regulatory strategy will be a potential approach and a great value-added contribution to avoid Regulatory roadblocks.
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January 19, 2021 Regulatory Affairs, Regulatory Medical WritingClinical 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 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 23, 2020 Medical Devices, Compliance, Audit and Validation, Regulatory AffairsYou may know that the Medical Device Coordination Group (MDCG) has released a Q&A document related to previously released guideline - MDCG 2020-4: guidance on temporary and extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions.
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November 19, 2020 Compliance, Audit and Validation, Regulatory AffairsThe Center for Drug Evaluation and Research (CDER) has recently launched two (2) quality management pilot programs for Active Pharmaceutical Ingredients (APIs) and Finished Dosage Forms (FDFs). The purpose of the pilot programs is to gain insight from the third-party assessments of the manufacturer’s quality management system (QMS) and enhance the future devel
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November 18, 2020 Compliance, Audit and ValidationIt is well known that COVID-19 has pushed many organizations to drive their auditors and the compliance teams adopt the right technology to perform remote audits. While remote audit techniques are similar to those of traditional audits, they leverage electronic means to obtain audit evidence for evaluations.
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September 30, 2020 Compliance, Audit and Validation, Regulatory AffairsTo support manufacturers during COVID-19, the EMA has updated guidance on the Regulatory expectations for the medicinal products. A new section of temporary flexibilities is added to inputs on good manufacturing practices (GMP), and good distribution practices (GDP). The new development is aimed at responding to the increased demand for medicinal products amid COVID-19.