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Ahmedabad, 380060
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+91 6 356 353 636

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 https://zenovel.com/regulatory-services/

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

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