Zenovel Thaltej, Ahmedabad, Gujarat

GCP Service
Risk Based Monitoring in BE Studies RBM in Patient Based PK Studies Monitoring of Phase-I, II, III trials PK-Stat, GCP Consultation Clinical Trial Monitoring GCP Training CRO Setup for USFDA/ EMA CRO Upgradation SOP Development Automization of Trial Process e-CRF, LMS, DMS Software Support
Regulatory Affairs Services
Registration and self-identification i.e. D-U-N-S number, FEI number request IND, NDA, ANDA, IMPD Application Marketing Authorization Application (MAA) to Europe MAAs for Biosimilar product Certification of suitability for EU Dossiers for emerging countries
GMP Services
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
Medical Writing Services
Clinical protocol writing for BE, Phase I, Phase II, Phase III, Phase IV Trials and Patient-based PK studies ICF, documents and brochures Concept Sheet for ANDA submissions Investigator Brochures ICH E3 and CDISC compliant CSR Clinical Study Report Protocol Development for proof of concept Trials