Our core competencies are based on quality, compliance, integrity, and understanding of the industry’s needs, making us the preferred partner for pharmaceutical companies seeking success in clinical and regulatory endeavors.
We offer an all-inclusive range of clinical trial services, from Phase I to Phase IV, including patient-based bioequivalence (BE) and pharmacokinetic (PK) studies, as well as therapeutic-based research tailored to meet specific client needs.
With over 17 years of industry experience across various therapeutic areas.
With more than 1500 GCP monitoring, around 200-300 BA/BE studies audit, 150 Phase I, 20 Phase II, 45 Phase III, and 18 Phase IV studies, along with medical device trials
Ensuring compliance with global regulations with team members across key global regions like India, USA, Canada, EU; more than 25 countries across the Globe.
Experts in patient-based bioequivalence (BE) studies, first-in-human trials, and complex phases of clinical trials (Phase I-IV).
Skilled teams in Clinical Development, Regulatory Affairs, GMP Auditing, and adept as per requirements.
We ensure that your facility and staff are fully prepared to pass FDA inspections, providing the necessary support for inspection readiness.
We utilize our expertise in pharmaceutical production plant design, regional building resources, architectural restrictions, and regulatory requirements to assembly GMP compliant pharmaceutical and biotech projects.
Audits performed at manufacturing sites in India, China, Vietnam, S. Korea, Taiwan, Malaysia, Turkey, USA, Europe, UK, and many others
Having conducted numerous audits, Zenovel now has a GMP Audit Report Library with Long Validity of GMP Audit Reports
Team of experts with 20+ years of experience in the GMP Domain
Strong In-house SOPs and Training Systems to perform the audits First of few companies to introduce concept of GMP monitoring
Our team excels in navigating the complex regulatory landscape, offering comprehensive services that ensure timely regulatory submissions with all necessary compliance documents. We guarantee that your products meet stringent global guidelines and regulations.
Team of experts with 15+ years of experience in designing and implementing Regulatory Strategies in compliance with global regulatory standards.
All-round competencies in Regulatory Affairs domain including all fine aspects covering – Dossiers, Site transfers and Post approvals.
All-round competencies the in quality assurance domain including all fine aspects covering – Process Validations, Documentation, In-Process quality assurance, Deviations and Change controls.
More than 125+ MAA Submission experience (Dossier).
More than 300+ post approval Submission experience to various regulatory agencies.
Experience for the review of manufacturing documents like batch manufacturing record, process validation protocol and report, batch packing record and stability protocol.
Involved in anticipating regulatory issues in drug development and work to eliminate/minimize regulatory issues.
Hands-on experience of eCTD software for EU and US.
Expertise in clinical and nonclinical writing
Expertise in admin documentation (especially Module 1).
Hands-On experience in Dossier review for Regulated and semi-regulated market.
Expert in dossier extension. Especially for gap assessment of one market to another.
Documentation and review of data of executed development, feasibility and scale-up batches.
Cover IT solutions, preclinical support, CMC development, and intellectual property protection, offering a comprehensive one-stop solution for all your needs.
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