Certifications
Drug Licence Copy Form-28
Form 28 in India is essentially a manufacturing licence for certain categories of drugs under the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945—specifically for manufacturing drugs other than those specified in Schedules C and C(1) (which cover biological and certain special products).
Form 28 acts as both a gatekeeping tool (ensuring only compliant manufacturers can operate) and a compliance checkpoint (through inspections, staff qualifications, and GMP adherence).
ISO 9001-2008 Certificate
ISO 9001:2008 certification impacts an organization’s credibility by signaling to customers, regulators, and business partners that the company follows internationally recognized quality management practices.
ISO 9001:2008 certification is like a quality seal—it doesn’t just say you follow good practices, it proves it through an independent, internationally recognized audit process.
ISO 13485-2003 Certificate
ISO 13485:2003 certification impacts an organization’s credibility—especially in the medical device industry—by proving that its quality management systems meet internationally recognized, sector-specific standards.
ISO 13485:2003 acted as a foundational global benchmark for medical device manufacturers—strengthening credibility, ensuring regulatory confidence, and enabling access to key markets.
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