SQA Regulatory Surveillance Summary for 3Q/4Q 2024
Review key 2024 regulatory shifts still influencing 2025—covering pharma, medical devices, AI, cosmetics, and global compliance strategies.
SQA Regulatory Surveillance Summary for May and June 2024
SQA Regulatory Surveillance Summary for May and June 2024 By: Laurel Hacche, Rocio Cabeza, and Debra Cortner Agência Nacional de Vigilância Sanitária (ANVISA) ANVISA will use Analysis of Equivalent Foreign Authorities for Inspection and GMP Certification Process, 03 May 2024 In the Official Gazette of the Union, ANVISA has published the Normative Instruction (IN) 292/2024, which […]
SQA Regulatory Surveillance Summary for March and April 2024
SQA Regulatory Surveillance Summary for March and April 2024 By: Laurel Hacche, Rocio Cabeza, and Debra Cortner Brazil: Agência Nacional de Vigilância Sanitária (Anvisa) Anvisa Extends the Validity Period of the Certificate of Good Manufacturing Practices to Four Years, 22 March 2024 The validity of the Certificate of Good Manufacturing Practices (CBPF or cGMP) of […]
SQA Regulatory Surveillance Summary for January and February 2024
SQA Regulatory Surveillance Summary for January and February 2024 By: Laurel Hacche, Rocio Cabeza, and Debra Cortner Agência Nacional de Vigilância Sanitária (ANVISA) ANVISA Publishes New Edition of the Biovigilance Manual, 17 January 2024 In Brazil, biovigilance covers a set of monitoring and control actions, ranging from donation to the clinical evolution of a recipient […]
SQA News | Fall 2023
Wins & Challenges October marked an incredible year since joining SQA Services. I regularly reflect upon how blessed I am to be a part of this organization. We are a mighty team providing indispensable services to many of the most influential companies in the world. Earlier this year, we took time as a leadership […]
SQA Regulatory Surveillance Summary | Monthly Update 2023 – July and August 2023
SQA Regulatory Surveillance Summary for July and August 2023 By: Laurel Hacche, Rocio Cabeza, and Debra Cortner Agência Nacional de Vigilância Sanitária (ANVISA) ANVISA Carries Out Health Inspection Actions in Food Supplement Industries in Rio de Janeiro, 10 July 2023 During the week of 12-16 June 2023, ANVISA and state and municipal health surveillance agencies […]
SQA Regulatory Surveillance Summary | Monthly Update 2023 – May And June
SQA Regulatory Surveillance Summary for May and June 2023 By: Laurel Hacche, Rocio Cabeza, and Debra Cortner Agência Nacional de Vigilância Sanitária (ANVISA) Understanding the New Rules for Clinical Analysis Laboratories, 12 May 2023 ANVISA has updated the standards that deal with the technical requirements for the operation of laboratories that perform collection, examination, and […]
SQA News | Summer 2023
Wins & Challenges It’s hard to believe how quickly eight months have flown by at SQA. It has been such an amazing experience getting exposure to all our client’s challenges and successes. I have enjoyed seeing a broader spectrum of the industries from which I came, Aerospace and Energy, by observing how other companies […]
SQA News | Spring 2023
Wins & Challenges I’m so excited to give everyone an update on some big news that’s happened over the last six months! Big wins for SQA and some challenges along the way and a new chapter in my life moving forward. As you likely read in our press release in late ’22, I’ve transitioned to […]
SQA Regulatory Surveillance Summary | Monthly Update 2022 – July/August
SQA Regulatory Surveillance Summary for July and August 2022 Health Canada Counterfeit COVID-19 Antigen Rapid Test Kits Found in Ontario, 05 August 2022 Health Canada is warning consumers about counterfeit BTNX Rapid Response COVID-19 antigen rapid test kits (25-pack boxes) found in Ontario. The counterfeit devices were sold online by a distributor named Healthful Plus […]