Wisdom Healthcare Solutions

Wisdom Healthcare Solution is a leading Global knowledge-based company where regulatory expertise meets unwavering commitment to time, quality and compliance. We have established ourselves as a trusted partner in Pharmaceutical healthcare industry, dedicated to navigating the complexities of regulatory frameworks and ensuring that our clients achieve their goals with confidence. Integrity, Excellence, and Innovation is our working mantra. Our core expertise and end to end support includes but not limited to: Regulatory Affairs: - Activities related to CDSCO - Activities Related to CBN (Central Bureau of Narcotics) - Activities related to FDA - Activities Related to NCB (Narcotics Control Bureau) - Medical Devices and Cosmetics Licensing - Clinical Trials GCP and GMP Services: - Comprehensive GCP (Good Clinical Practice) services - Monitoring of Bioequivalence/Clinical Trials Studies for various regulatory markets like USFDA, EMA, ANVISA, WHO etc. - Retrospective and onsite Auditing services of the CROs for review of clinical, bioanalytical and statistical data of BE studies including complex molecule for various regulatory markets like USFDA, EMA, WHO,ANVISA etc. - GMP (Good Manufacturing Practice) services, including audits, Gap analysis, end to end plant setup including engineering project and upgradation. - WHO GMP/ COPP application, FDA GMP application and EU GMP application Other Activities - CTD and eCTD dossier preparation for various semi regulatory and regulatory authorities - Medical writing - Manuscript writing - All Air cargo related activities - PTL/DSIR applications Together, we can navigate the complexities of the healthcare landscape and achieve your goals with confidence. Ready to elevate your regulatory compliance and healthcare solutions? You are just one step far towards success. Connect with us today or write us on bd@wisdomhealthcare.co.in