16/03/2024
๐ ๐๐๐ฏ๐ข๐ ๐๐ญ๐ข๐ง๐ ๐๐ฅ๐จ๐๐๐ฅ ๐๐๐ ๐ฎ๐ฅ๐๐ญ๐จ๐ซ๐ฒ ๐๐ฑ๐๐๐ฅ๐ฅ๐๐ง๐๐ ๐ฐ๐ข๐ญ๐ก ๐๐ฌ! ๐
At ๐น๐๐๐ ๐ท๐๐๐๐๐ ๐๐ณ๐๐๐๐๐๐๐, we take pride in offering unparalleled Global Regulatory Affairs services, providing a compass for your journey towards regulatory success. ๐โจ
๐ ๐ข๐๐ฟ ๐๐ฒ๐ ๐ข๐ณ๐ณ๐ฒ๐ฟ๐ถ๐ป๐ด๐:
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Optimized Decision Points
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Risk Mitigation
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Streamlined Pathways
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Flexible Approaches
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Transparency & Problem-Solving
๐ผ ๐๐ถ๐๐ฒ๐ฟ๐๐ถ๐ณ๐ถ๐ฒ๐ฑ ๐ฅ๐ฒ๐ด๐๐น๐ฎ๐๐ผ๐ฟ๐ ๐๐ณ๐ณ๐ฎ๐ถ๐ฟ๐ ๐ฆ๐ฒ๐ฟ๐๐ถ๐ฐ๐ฒ๐:
๐ฌ Pharma, Biotech, Medical Devices: From registrations to marketing approvals, we specialize in diverse regulatory affairs services across the pharmaceutical, biotech, and medical devices sectors globally.
๐ GxP Compliance: Our comprehensive GxP compliance services cover GMP, GLP, GCP, GDP, Due diligence, Validations, CSV, Data integrity, and more.
๐ Global Submissions & Compliance: Regulatory compilation, technical writings, and GMP validation documentation support as per global standards, including USFDA, EMA, TGA, MCC, UK-MHRA, SFDA, GCC, CFDA, RoW, Russia & CIS, Indian DCGI & CDSCO, and more.
๐ป Technical Documentation Support: From Sugam Portal submissions for CDSCO/DCGI to Device Master File preparation and ISO certifications, we've got you covered.
๐ USFDA & International Registrations: Navigate regulatory filings to USFDA (e.g., 510(k)), US agent and e-filing support, CE marks, UKCA marks, and registrations across the EU.
๐ฌ Clinical Evaluation & Risk Management: Expertise in risk analysis and risk management for all classes of medical devices and IVDs as per ISO 14971 requirements, clinical evaluations as per Meddev 2.7.1 Rev. 4, and ISO 14155 requirements.
Join us in embracing regulatory excellence and ensuring a seamless ๐ ๐ฅ๐จ๐๐๐ฅ market presence.
๐๐ก ๐๐ผ๐ป๐๐ฎ๐ฐ๐ ๐๐:
๐ https://lnkd.in/fhS2z8y / www.raajgprac.com
๐ง rajashrio@gmail.com, raajgprac@gmail.com
๐ 9819125208, 9821144706