ZENOVEL

About

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.

Keywords

regulatory affairs, gcp, clinical research, bioequivalence, phasei, phaseii, phaseiii, medical writing, scientific writing, cro audit, global audits, global monitoring, cro development, gcp training, regulatory training, gmp training, gxp consultation, api & rld sourcing, preclinical audit, toxicology audit, glp audit, gmp

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