CDSCO Compliance Services
At Qualitance India, we specialize in providing end-to-end regulatory support for CDSCO (Central Drugs Standard Control Organization) compliance – India’s premier regulatory authority for pharmaceuticals, medical devices, cosmetics, diagnostics, and clinical trials. Navigating the CDSCO regulatory framework is a critical step for businesses looking to manufacture, import, or market healthcare products in India. Our experienced regulatory team ensures that your business meets all compliance requirements efficiently and accurately.
What is CDSCO?
CDSCO operates under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India. It is responsible for the approval of new drugs and clinical trials, laying down the standards for drugs, control over the quality of imported drugs, and coordination of the activities of State Drug Control Organizations.
Whether you’re an international company looking to enter the Indian market or a domestic manufacturer aiming to launch a new product, aligning with CDSCO guidelines is not optional—it’s mandatory. That’s where Qualitance India comes in.
Our CDSCO Services
We offer a comprehensive range of CDSCO services tailored to your business needs, including:
Regulatory Consultation: Detailed guidance on classification, licensing, and applicable CDSCO requirements based on your product category (medical device, drug, cosmetic, etc.).
Registration & Import Licensing: Assistance in obtaining registration certificates and import licenses for drugs and medical devices, including preparation and submission of Dossiers as per CDSCO format.
Manufacturing License Support: End-to-end support in obtaining manufacturing licenses, including Form 25, Form 28, and site inspections.
Clinical Trial Approval: Expert guidance for clinical trial approvals, study designs, and submission as per Indian regulatory standards.
Post-Market Compliance: Help with Adverse Event Reporting (AER), periodic safety updates, and renewal of licenses.
Digital Submissions via SUGAM Portal: Assistance with digital filings through the CDSCO’s online SUGAM portal for streamlined submissions and faster approvals.
Why Choose Qualitance India?
Experienced Professionals: Our team has deep expertise in the regulatory landscape and real-time experience in handling complex CDSCO cases.
Customized Solutions: We provide tailored services based on the unique needs of your organization and product.
Compliance-Driven Approach: We ensure timely submissions and minimize the risk of rejection or delays by following a proactive, compliance-first process.
End-to-End Support: From initial application to post-approval monitoring, we manage the entire lifecycle of your regulatory needs.
Get in touch with Qualitance India today to streamline your CDSCO compliance process and enter the Indian healthcare market with confidence and clarity.