Quality Pledge | Monash Biotech

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The Quality Pledge,

at Monash Biotech,

Our commitment to excellence is not just a pledge; it`s the cornerstone of our identity. We have been founded with a resolute philosophy - to provide the finest quality products and process-oriented services to the micromanipulation industry worldwide.

Foundations of Trust:

Our journey is built on the foundations of trust, and we aim to be more than just a medical device manufacturer. We strive to be a strong and reliable partner for both individual and markets. Our growth is rooted in our own strength, and our success is intertwined with the success of those we serve.

Legal, Moral, and Ethical Standards:

The reputation of Monash Biotech rests on the legal, moral, and ethical behavior of our employees. We understand the weight of this responsibility and, therefore, mandate strict compliance with the law and uphold high standards of business conduct. Our actions are guided by a business code that reflects our values, a quality policy that ensures excellence, and a shared goal of delivering exemplary customer service to our global clientele, vendor partners, and manufacturing suppliers.

Compliance and Certification:

Our commitment to quality is not just a promise but a practice. Monash Biotech operates in compliance with the current Good Manufacturing Practices (CGMP`s), additionally it adheres to ISO 13485:2016 regulations and Central Drugs Standard Control Organization (CDSCO) Certificate. Our detailed production protocols and quality control test procedures ensure that every product leaving our facility is of the highest standard.

Certified Excellence:

The Standard Mouse Embryo Assay (MEA) Test, Endotoxin Test, Sterility Test certifications, and irradiated with Gamma Radiation underscore our dedication to delivering products that meet the stringent criteria of quality assurance. Every item that bears the Monash Biotech name undergoes meticulous manufacturing and quality assays under the direct supervision of trained personnel with decades of experience in Assisted Reproductive Technology (A.R.T.).

D-U-N-S^® Number

Monash Biotech is proud to be a D-U-N-S^® Number verified company. Our D-U-N-S^® Number is 86-143-1004. This unique identifier verifies our business identity and establishes trust with our partners and clients. By choosing Monash Biotech, you can be confident in the reliability and credibility of our company.

BSI Certificate of Registration for Quality Management System ISO 13485

A Licence for Monash Biotech to Manufacture for Sale or for Distribution of Class A or Class B medical Device

Certificate of Recognition by Startup India to Monash Biotech

Life Membership Certificate of Vadodara Chamber of Commerce and Industry

Certificate of ZED Bronze Award to Monash Biotech

A Loan Licence for Monash Biotech to Manufacture for Sale or for Distribution of Class A or Class B medical Device

Experience the Excellence:

Choosing Monash Biotech means choosing a commitment to excellence that goes beyond words. It`s a commitment woven into the fabric of our organization, reflected in every product we deliver, and a promise upheld by every member of our team. Experience the excellence that defines Monash Biotech - where quality is not just a pledge but a way of life.