Overview

As a global leader in the pharmaceutical industry, we specialize in providing comprehensive solutions for three key areas: Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Regulatory Affairs. Our GCP services include: Risk-based monitoring in BE studies RBM in patient-based PK studies Monitoring of Phase-I, II, III trials PK-Stat and GCP consultation CRO setup for USFDA/EMA CRO upgradation GCP training SOP development Automization of trial process E-CRF, LMS, DMS support Wide therapeutic range experience Different study designs Our GMP services include: API and Formulation Plant Audit GMP consultation GAP/Root Cause Audit EUGMP/USFDA/WHO Plant Setup and Upgradation from local GMP to EUGMP/USFDA/WHO GMP training Computer system validation Designing of procedures and SOPs, WI, policies, forms/formats, OOS procedure optimization, and change control Our regulatory affairs services cover: Regulatory strategy Dossier preparation to submission Product registration in major regulatory bodies such as USA, Europe, MHRA, WHO, ANVISA, MCC, and TGA We understand the importance of safe and effective medicines, which is why we provide a one-stop solution to the pharmaceutical industry with our expertise in GCP, GMP, and regulatory affairs. Our team of experts has over 17 years of experience and is dedicated to helping your organization achieve success. Contact us today to learn more about our services and how we can help you achieve your goals.