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CDSCO Registration

The Central Drugs Standard Control Organization (CDSCO) is Indiau2019s national regulatory authority responsible for the approval, oversight, and regulation of drugs, medical devices, and cosmetics. Established under the Directorate General of Health Services, CDSCO ensures that products introduced into the Indian market are safe, effective, and compliant with regulatory standards. CDSCO registration is mandatory for companies looking to import, manufacture, or distribute pharmaceutical products and medical devices in India

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CDSCO Registration

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  1. CDSCO Registration CDSCO registration is the main requirement for Indian companies which want to import, manufacture or distribute pharmaceutical products and medical devices in India. CDSCO registration is a regulatory approval emanating from The Drugs & Cosmetics Act, 1940. Importance of CDSCO Registration It is mandatory for companies importing, manufacturing, or distributing pharmaceuticals and medical devices in India. Without proper registration, products cannot be legally sold in the Indian market. It ensures safety, compliance, and adherence to Indian regulatory standards. Types of CDSCO Registration Drug Medical Device Registration Cosmetics Registration Registration Challenges in CDSCO Registration Complex Regulatory Framework Lengthy Approval Process Compliance with Good Manufacturing Practices (GMP) Frequent Changes in Regulatory Requirements Coordination with Multiple Authorities How do SKMC Global Help with CDSCO Registration? CDSCO Registration Assistance: A comprehensive support of registration of drugs, medical devices, and cosmetics. Document Preparation and Submission: To ensure that all the necessary documents are prepared and submitted directly to the respective regulatory standards. Consultancy and Guidance: Expert recommendations on issues of compliance, approval processes, and regulatory requirement. Services for Compliance after Approvals: Continually support in ensuring compliance with CDSCO regulations. For more information, visit https://www.skmcglobal.com/service/cdsco-registration info@skmcglobal.com www.skmcglobal.com

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