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Regulation/Guidelines

COVID-19 Home Testing Using Rapid Antigen Tests (RATs)

Rapid Antigen tests aim to confirm positive test results of covid-19 infection in people possessing potential symptoms related to the disease. The rapid antigen home tests are accessible as they can be used wherever the patient is and can provide the test results quickly.

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Regulation/Guidelines

New Regulations for Medical Devices Industry by CDSCO

Nowadays, therapeutic treatment based on medical devices is providing technologically advanced solutions for the management, diagnosis, treatment,mitigation or prevention of several diseases. Thus, the demand continues to grow in the market at a tremendous rate leading to a renewed interest in the scientific development and research in the field of […]

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News

CliniExperts Facilitating Fast Track Approval of COVID-19 Diagnostic Kits in India

Delhi based CliniExperts, a company that specialises in regulatory approval of diagnostic kits, has helped four diagnostic companies recently in getting Indian regulatory approval of their COVID-19 diagnostic kits

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News

Self-Assessment/Audit of Unit for GMP/GLP Compliance

The Indian government has brought about some major changes with regards to the rules and regulations governing the manufacturing to enhance the quality of products used in the healthcare industry. As India being a major market for the healthcare-related products and its services, these modifications to the existing regulations are […]

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Regulation/Guidelines

CliniExperts Aided The Faster Approval Of Edinburgh Genetics Colloidal Gold Immunoassay And Whole Blood Collection COVID-19 Kits

CliniExperts successfully helped in getting approval of Edinburgh Genetics Colloidal Gold Immunoassay and Whole Blood Collection kits for testing COVID-19.The pre-approved COVID-19 testing kits by the Medicines and Healthcare Products Regulatory Agency (MHRA, UK) are now also approved by the Central Drugs Standard Control Organization (CDSCO) and validated by Indian Council of Medical Research (ICMR).

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Insight

Sugam – CDSCO Portal for Online Application

Indian Government has chosen to join the foray and ride the digital wave through SUGAM, launched on 14 November, 2015

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Regulation/Guidelines

Accelerated Approval Of RealCycler CORO-G Real Time PCR Kits By CliniExperts

RealCycler CORO-G Kits v.5.3 is Real-time PCR Test Kit, using Taqman-like hydrolysis probes technology, in combination with CHIC technology for the design of the internal amplification control. The kits allows the detection of Coronavirus SARS-CoV-2 and Sarbecovirus E gene RNA in clinical samples using realtime PCR.

News

Biocan Launches Rapid Antibody Test Kits For Novel Coronavirus (COVID-19)

Biocan Diagnostic Inc brings in India a rapid testing kit named Tell Me Fast. A rapid test for the qualitative detection and differentiation of novel coronavirus (COVID-19) IgG & IgM antibodies in human whole blood, serum, and plasma samples, approved by the Central Drugs Standard Control Organisation (CDSCO) and (United States Food and Drug Administration) USFDA. CliniExperts helped in the rapid approval of the testing kit Tell Me Fast developed by Biocan Diagnostics Inc in India

Regulation/Guidelines

Release of Consignments of Vaccines and In-vitro Diagnostics in COVID-19 Pandemic

CDSCO released the notification for release of vaccines, IVDs and blood products (sampled 100% testing) from the ports after reviewing the documents, protocol, and certificate of release batch by the manufacturer and past satisfactory history of the product.

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