Dot Compliance

JUNE 16, 2022

Millions of dollars are lost by manufacturers every year due to regulatory non-compliance issues and related lawsuits. We continuously hear of infractions and warnings issued to companies for lack of regulatory compliance. The QMS supports the manufacturers, leading to ISO confirmation and FDA compliance.

FDA 52

FDA Regulatory Compliance Compliance Governance 52

Dot Compliance

JANUARY 14, 2022

Common risk areas often include (but aren’t limited to): Cybersecurity Audit management Government pricing General data protection regulation. Key risk management regulations for Life Sciences companies include: ISO 12485:2016. This internationally recognized standard was revised and published in 2016. Source: [link].

Compliance 52

Compliance FDA Regulatory Compliance Governance 52

SQA

OCTOBER 18, 2022

List Health Advance as an “Official Canadian Distributor” Include the text “Health Canada Approved” (Claims of endorsement by government authorities, such as Health Canada, are not permitted.). United States Food and Drug Administration (FDA) – Regulations and Guidances. .” instead of BTNX Inc.

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 Compliance 40

Drug & Device Law

DECEMBER 29, 2023

2023) (federal government may unilaterally obtain dismissal of FCA claims, and calling the constitutionality of the FCA’s private enforcement mechanism into question) ( here ); Quishenberry v. Further, the plaintiffs’ arguments were based on scientific standards “not utilized by the FDA,” and thus preempted. Polansky v. 3d 239 (Cal.

FDA 105

FDA US Department of Health and Human Services COVID-19 Informed Consent 105