Company Profile

FOR ECTD GLOBAL PVT. LTD. POWERING COMPLIANCE. ACCELERATING ACCESS. YOUR GLOBAL REGULATORY ALLY. AT ECTD GLOBAL PVT. LTD., WE SPECIALIZE IN EMPOWERING PHARMACEUTICAL, BIOTECHNOLOGY, AND MEDICAL DEVICE COMPANIES WITH SEAMLESS ELECTRONIC SUBMISSIONS AND COMPREHENSIVE REGULATORY LIFE CYCLE MANAGEMENT. WITH DEEP DOMAIN EXPERTISE IN ECTD (ELECTRONIC COMMON TECHNICAL DOCUMENT) FORMATS, WE SIMPLIFY THE COMPLEXITIES OF REGULATORY COMPLIANCE AND EXPEDITE SUBMISSIONS TO MAJOR HEALTH AUTHORITIES SUCH AS THE USFDA, EMA, MHRA, TGA, HEALTH CANADA, AND CDSCO. OUR TEAM OF SEASONED REGULATORY PROFESSIONALS DELIVERS END-TO-END SOLUTIONS TAILORED TO EVERY STAGE OF THE REGULATORY JOURNEY—RIGHT FROM DOSSIER COMPILATION, FORMATTING, AND PUBLISHING TO VALIDATION, ELECTRONIC SUBMISSION, AND POST-APPROVAL MAINTENANCE. WE HANDLE A WIDE ARRAY OF SUBMISSIONS, INCLUDING: NDA, ANDA, IND, MAA, DMF VARIATIONS, SUPPLEMENTS, AMENDMENTS ANNUAL REPORTS AND LIFE CYCLE UPDATES OUR SERVICES ARE FULLY ALIGNED WITH ICH GUIDEL