Global leader in Monitoring and Auditing for BE, CT, Phase-I, Phase-II, Phase-III, PKPD, GMP – API, Formulation, F&D, GAP Audits, Plant Setup/Upgradation, Preclinical Audits, Toxicity Study Monitoring, Regulatory Affairs: Full fledge Services Detailed Services: GCP Services: Risk Based Monitoring in BE Studies RBM in Patient Based PK Studies Monitoring of Phase-I, II, III trials PK-Stat, GCP Consultation Reach across the globe GCP Training CRO Setup for USFDA/ EMA CRO Upgradation SOP Development Automization of Trial Process e-CRF, LMS, DMS support Wide Therapeutic Range Experience Different Study Designs Regulatory Affairs Services: From Regulatory Strategy, Dossier Preparation to Submission Product Registration in Major Regulatory USA, EUROPE, MHRA, WHO, ANVISA, MCC, TGA, NMPA GMP Services: API and Formulation Plant Audit. GMP Consultation GAP/Root Cause Audit EUGMP/USFDA/WHO Plant Setup, Upgradation from local GMP to EUGMP/USFDA/WHO API and Formulation Plant Audit GMP Consultation GAP Audit Root Cause Audit EUGMP/USFDA/WHO Plant Setup GMP Training Upgradation from local GMP to EUGMP/USFDA/WHO/PIC/s Computer system validation Designing of Procedures and SOPs, WI, Policies, Forms/Formats OOS Procedure Optimization Change Control Sourcing Services: API Sourcing, Product Sourcing and RLD Sourcing. With team of experts having more than 17 years of experience, focusing to provide one stop solution to pharmaceutical industry to help safe and effective medicine come in market with expertise in GCP, GMP and Regulatory Affairs.