Regulation and Ethics

At Brine Medical, we uphold the highest standards of ethics and integrity in all our operations. We rigorously adhere to all applicable federal, state, and international laws and regulations. Our internal policies and procedures are designed to ensure ethical business practices and compliance across all levels of our organization.

FDA Regulations

Brine Medical complies with the U.S. Food and Drug Administration (FDA) regulations governing the development, testing, and approval of pharmaceutical products. We maintain comprehensive records and adhere to Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) to ensure the safety, efficacy, and quality of our therapies.

Environmental Regulations

Our marine bioprospecting activities are conducted in compliance with all relevant environmental laws and international treaties. We follow the Nagoya Protocol on Access and Benefit-sharing to ensure fair and equitable sharing of benefits arising from the utilization of genetic resources.

Informed Consent

Brine Medical ensures that all participants in our clinical trials provide informed consent. Participants are fully informed about the nature, purpose, potential risks, and benefits of the research, in accordance with the principles of the Declaration of Helsinki and the Belmont Report.

Animal Welfare

We are committed to the humane treatment of animals used in our research. Our practices comply with the Animal Welfare Act and the guidelines set forth by the Institutional Animal Care and Use Committee (IACUC), ensuring that all animal research is conducted ethically and responsibly.

Reporting, Transparency, and IP

Annual Reports

We produce detailed annual reports that provide comprehensive information on our financial performance, research milestones, and strategic initiatives. These reports are available upon request and are designed to ensure full transparency and accountability to our stakeholders.

Clinical Trial Reporting

Brine Medical registers all clinical trials with ClinicalTrials.gov and other relevant databases in compliance with the International Committee of Medical Journal Editors (ICMJE) guidelines. We ensure timely disclosure of study designs, methodologies, and results to maintain transparency and public trust.

Patents

Brine Medical actively secures intellectual property rights for its innovations through the filing of patents with the United States Patent and Trademark Office (USPTO) and other international patent offices. Our patent portfolio includes several marine-derived compounds and their isolation and synthesis methods, providing robust protection for our proprietary technologies.

Licensing

We engage in strategic licensing agreements that allow us to collaborate with other entities to co-develop and commercialize new therapies. These agreements are structured to ensure compliance with all relevant legal and regulatory requirements and to maximize the value of our intellectual property.

Corporate Governance

Board of Directors

Board of Directors: Our Board of Directors consists of seasoned professionals with extensive experience in the pharmaceutical and biotechnology sectors. The Board is responsible for providing strategic oversight and ensuring that Brine Medical operates in a manner that is ethical and in the best interests of its stakeholders.

Audit Committee

The Audit Committee oversees the integrity of our financial reporting, the effectiveness of our internal controls, and our compliance with legal and regulatory requirements. The Committee ensures that our financial statements are accurate and that we maintain high standards of corporate governance.