BaysMarting Consulting (BMC) is a Life Science consulting firm dedicated to providing expertise in regulatory, quality, and clinical compliance to support research and development in the healthcare, biotech, and life sciences industries. BMC aims to be the premier diverse STEM consulting partner for biotech, pharmaceutical, medical device, and healthcare providers seeking regulatory expertise, clinical trial support, and quality system compliance.

BMC specializes in creating comprehensive technical dossiers for FDA and global submissions, ensuring thorough alignment with regulatory standards. BMC reviews and advises on scientific protocols and test reports, delivering tailored insights to optimize compliance and streamline processes. With a focus on innovation and strategic execution, BMC helps clients navigate today’s complex challenges in bringing biotechnology products to market efficiently and effectively.

Core Competencies

• US 510(k) and PMA Premarket Application/EU Technical Files, Design Dossiers, eCTDs
• In-Vitro Diagnostics, Medical Devices, Cosmetics, OTC Drugs, Reagent Manufacturing Regulations
• Global Clinical Affairs submission strategies, IRB, Informed Consent Regulations
• Research & Development Design Controls- Code of Federal Regulations-21 CFR 820
• CLIA, Histotechnology, Molecular Biology, Immunohistochemistry, Biotechnology Industry Regulations
• FDA Quality System Regulations and ISO 13485 Med Device Quality Management Systems, Risk Management
• Emergency Use Authorization Applications for COVID-19, Healthcare
• Compliant Labeling: Global labeling and marketing and advertising regulations

Differentiators

BaysMartin Consulting, LLC (BMC) brings over 20 years of expertise in regulatory, clinical, and quality management, with a proven track record of supporting Fortune 500 and multi-billion-dollar corporations in achieving global marketing authorizations across diverse disease disciplines, including spinal cord stimulation, deep brain stimulation, COVID-19, lung disease, orthopedics, eyecare, immunohistochemistry, cervical cancer, colon cancer, and more. As a minority-owned business, BMC offers diverse perspectives and inclusive problem-solving approaches, fostering innovative and effective solutions. With extensive experience navigating complex international regulatory landscapes, BMC ensures seamless collaboration across all technical and organizational levels. Additionally, BMC provides specialized notary and Apostille services tailored to life sciences, biotech, and healthcare industries, ensuring timely authentication of critical documents for global regulatory submissions and compliance.

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