ZENOVEL

At Zenovel, we specialize in delivering high-impact solutions across three critical areas of the pharmaceutical industry: Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Regulatory Affairs. With over 20 years of global experience, we help pharma and biotech companies ensure their trials, facilities, and products meet international regulatory standards — efficiently and effectively. 🔬 GCP Services We support end-to-end clinical development with: • Risk-based monitoring for BE and PK studies • Oversight of Phase I–III trials • CRO setup and upgradation for USFDA/EMA compliance • GCP and PK-Stat consultation • SOP development and GCP training • Digital support: eCRF, LMS, DMS • Automation of trial processes • Expertise across diverse study designs and therapeutic areas 🏭 GMP Services We help clients strengthen manufacturing compliance with: • Audits for API and formulation sites • GAP/root cause analysis and consultation • Facility setup and upgrades to EUGMP/USFDA/WHO standards • Customized GMP training programs • Computer system validation • SOPs, policies, OOS procedures, and change control optimization 📑 Regulatory Affairs We guide regulatory success through: • Strategic regulatory planning • Dossier compilation and submission • Product registrations with USFDA, EMA, WHO, TGA, ANVISA, MHRA, MCC, and more Zenovel is your one-stop partner for compliance-driven growth. Our mission is to turn regulatory complexity into actionable, competitive advantage—helping partners scale safely, compliantly, and globally. Let’s connect if you’re looking to unlock efficiency, expand reach, or de-risk your path to market.