Compliances

Regulatory Compilation of all modules CTD-M1, M2, M3, M4, M5 and Global Submissions (pCTD, eCTD, ACTD, NEES formats) and Technical, CMC writings, GMP Validation documentation support as per USFDA, EMA, TGA, MCC, UK-MHRA, SFDA, GCC, CFDA, RoW, Russia & CIS, Indian DCGI & CDSCO and other country-specific requirements.

GxP compliance services which includes [GMP, GLP, GCP, GDP, Due diligence, Validations, CSV, Data integrity etc.