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Discover expert tips to avoid costly FDA submission mistakes in 2025. Learn how to ensure compliance, improve documentation, and accelerate product approval.
EU MDR vs. FDA 510(k) Medical device manufacturers aiming for global market access must navigate complex regulatory frameworks to ensure compliance. Two of the most critical regulatory pathways are the European Union Medical Device Regulation (EU MDR) and the United […]
IntroductionThe U.S. Food and Drug Administration (FDA) has recently approved a ground-breaking gene therapy for the treatment of Aromatic L-amino Acid Decarboxylase (AADC) deficiency, marking a significant advancement in the field of genetic disorders. This approval is a beacon of […]
The USFDA’s 2024 regulatory changes At Vigilare Biopharma, we understand the complexities and challenges that pharmaceutical companies face when navigating the ever-evolving regulatory landscape. The USFDA’s 2024 regulatory changes reflect a significant shift towards enhancing drug safety, efficacy, and accessibility. […]
The cosmetic facility that manufactures or processes a cosmetic product for distribution in the United States on December 29, 2022, must register each facility before July 1, 2024. Cosmetic facilities that first engage in the manufacturing or processing of a cosmetic product for distribution in the United States after December 29, 2022, must register within 60 days of first engaging in such activity or by July 1, 2024, whichever is later.
