Regulatory and Compliance
At CellBios, we are deeply committed to maintaining the highest standards of integrity, ethics, and compliance with all relevant laws and regulations. This page outlines the key compliance guidelines and frameworks we follow to ensure transparency, accountability, and ethical business practices across every aspect of our operations.
Our Quality Policy
CellBios develops, manufactures, and distributes high quality products that are safe and effective, meet all applicable regulatory requirements, and satisfy our customers in the market we serve. We ensure on meeting our customer expectations and requirements through innovation and continual improvement in design & development, products and processes and development of our people.
Regulatory Compliance
CellBios adheres to national and international healthcare regulations, industry standards, and best practices, ensuring the highest levels of safety, efficacy, and quality for our products. Our regulatory compliance includes, but is not limited to:
- Medical Device Rules, 2017
- ISO 13485:2016 Quality Management System Certification
- Good Manufacturing Practices (GMP)
We are fully committed to ensuring all manufacturing and distribution activities comply with these regulatory standards, reinforcing our dedication to delivering products that consistently meet and exceed customer expectations.
Corporate Governance
We are committed to upholding the principles of sound corporate governance. At CellBios, we operate with a focus on transparency, fairness, and accountability. Our leadership team ensures the company complies with all legal and regulatory requirements while aligning our activities with the best interests of our stakeholders, including customers, employees, and investors.
Quality Assurance and Control
Our Quality Assurance and Quality Control systems are designed to guarantee that all products undergo thorough testing and meet the highest quality standards. We operate state-of-the-art laboratories and production facilities, which are regularly audited and certified by regulatory bodies. By adhering to strict guidelines and Standard Operating Procedures (SOPs), we maintain the integrity and quality of every product we deliver.
Post-Market Surveillance
At CellBios, we are committed to ensuring the ongoing safety, efficacy, and performance of our medical devices once they are on the market. Our Post-Market Surveillance (PMS) program plays a critical role in monitoring the real-world performance of our products, collecting feedback from healthcare professionals, and identifying any issues that may arise during their use.
Our PMS program is designed to ensure that our medical devices maintain compliance with safety and quality standards throughout their entire lifecycle. We fully comply with both local and international regulations, ensuring ongoing adherence to global regulatory bodies and industry standards.
Ethical Practices
CellBios fosters a culture of ethical conduct across all our business operations. We are committed to maintaining the highest standards of integrity through the following principles:
- Anti-Bribery and Anti-Corruption: We enforce a strict zero-tolerance policy toward bribery and corruption. Our employees receive training on ethical business practices and are required to comply with anti-corruption laws at all times.
- Fair Competition: We adhere to competition laws and promote fair business practices to ensure a level playing field in the marketplace.
- Conflict of Interest: We expect our employees and partners to avoid situations that may lead to a conflict of interest and to promptly disclose any potential conflicts that may arise.
Privacy and Data Protection
At CellBios, we prioritize the privacy and confidentiality of our customers and partners. We are fully committed to complying with data protection laws, including the Personal Data Protection Bill (India) and international data privacy standards. All personal data is collected, processed, and stored securely, with robust measures in place to prevent unauthorized access or data breaches.
Health and Safety Compliance
We adhere to all relevant health and safety regulations to provide a secure and healthy work environment for our employees. Our comprehensive health and safety protocols are designed to prevent accidents and promote the well-being of all personnel working within our facilities.
Sustainability and Environmental Responsibility
CellBios is committed to sustainability and reducing the environmental impact of our operations. We comply with all environmental laws and regulations, ensuring our manufacturing processes are eco-friendly. Our commitment includes responsible waste management, energy conservation, and efforts to minimize our carbon footprint.
Reporting Non-Compliance
We encourage our employees, partners, and stakeholders to report any concerns related to non-compliance, unethical behavior, or violations of laws and regulations. Our robust whistleblowing policy ensures that all complaints are handled confidentially and without retaliation.
Continuous Improvement
CellBios is dedicated to the continuous improvement of our compliance processes, ensuring our operations remain aligned with the latest industry standards and regulatory requirements. We regularly review and update our compliance programs to reflect changes in laws, regulations, and best practices.