Looking for expert assistance with CRO qualification, system audits, study audits, GAP assessments, or for-cause investigations? ZENOVEL delivers comprehensive solutions to help you maintain the highest standards of compliance, quality, and operational excellence in clinical research. Let us help you identify gaps, optimize processes, and achieve your research objectives. #CROQualification #StudyAudits #GCPCompliance #GapAudits #ForCauseInvestigations #Zenovel #GCPAudit
ZENOVEL
制药业
Ahmedabad，Gujarat 10,493 位关注者
The Most Credible GxP and Regulatory Partner Globally, Risk Based Monitoring, BE/BA/Phase-I to IV, GMP Audits
关于我们
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.
- 网站
-
https://www.zenovel.com
ZENOVEL的外部链接
- 所属行业
- 制药业
- 规模
- 11-50 人
- 总部
- Ahmedabad，Gujarat
- 类型
- 合营企业
- 创立
- 2020
- 领域
- Regulatory Affairs、GCP、Clinical Research、Bioequivalence 、Phase-I、Phase-II、Phase-III、Medical Writing、Scientific Writing、CRO Audit、Global Audits、Global Monitoring、CRO Development、GCP Training、Regulatory Training 、GMP Training、GxP Consultation、API and RLD Sourcing、Preclinical Audit、Toxicology Audit、GLP Audit和GMP
产品
![点击此处查看GCP Services]()
GCP Services
临床试验管理软件
1) Independent Risk-Based Monitoring for, - Phase I-Phase IV trials - Bioequivalence Studies - Patient Based PK Studies - Clinical End-point studies - Medical Monitoring - Bio-Analytical and PK-Stat Monitoring - Toxicology/Pre-Clinical Studies 2) Independent Audit Solutions: - System Facility Audit: a. CRO Qualification/Requalification Audits b. GAP Audit - Study Audit: a. Retrospective Study Audit (Healthy/Patient) b. For-Cause Investigation Audit (Healthy/Patient) c. Pre-Inspection Readiness Audit (Healthy/Patient) d. QA Audit (Patient) e. Investigator Site Audit (Patient) f. Safety Assessment Audit (Healthy/Patient) 3) Sponsor Oversight Management: - CRO Identification - Budget Finalization, - Study Protocol, ICF, CSR, CRF Review - Project Management - Regulatory Query Resolution
地点
-
主要
获取路线
Science City Road
1113 Satyamev Eminence
IN，Gujarat，Ahmedabad，380060
ZENOVEL员工
-
Milan Modi
Director Of Operations at ZENOVEL | Auditor I Monitor I Clinical Research I Phase-I, II, III Trial | GMP | Regulatory Affairs
-
Rakesh Sutariya
CEO and Managing Director at Zenovel | Leading GCP - Clinical Trials, Bioequivalence, GMP and Regulatory Affairs | GXP Expert
-
Kashyap Shukla
Senior Manager Accounts at Zenovel | Account Management, Financial Accounting
-
Pinky Sutariya
Experienced Finance Professional || Dedicated to Business Development || Zenovel provides expert services in, GCP (Clinical Trial…
动态
-
? We’re Heading to CPHI & PMEC India India 2024! ?? ? ZENOVEL is excited to participate in CPHI India, from November 26th to 28th!? ? Let’s explore how Zenovel can deliver impactful regulatory and compliance solutions tailored to your pharmaceutical needs.? ? See you at #CPHIIndia2024!
-
-
At ZENOVEL, we are committed to driving progress in respiratory health through: ? Expertise in inhalation studies ensuring precise drug delivery. ? Comprehensive regulatory support for smooth approval processes. ? Patient-focused strategies to enhance study outcomes. ? Our mission is to support the development of therapies that restore hope and improve the quality of life for millions battling COPD. Let’s work together to create a future where every breath counts. ?? ? #WorldCOPDDay #COPD #InhalationStudies #RespiratoryHealth #Zenovel #InnovativeSolutions
-
ZENOVEL转发了
??Are You Inspection-Ready??? Ensuring compliance is non-negotiable in today’s highly regulated pharmaceutical landscape. Recently, ZENOVEL partnered with a valued client to conduct a comprehensive GMP Pre-Inspection Readiness Audit—a critical step in preparing for regulatory success. Our tailored approach went beyond the checklist: ? Identifying GAPs before they become findings ? Strengthening operational processes ? Ensuring robust compliance with regulatory standards ??Inspection readiness audits are your first line of defence against non-compliance. Whether it’s GMP, GCP, or other regulatory frameworks, ZENOVEL ensures you're always a step ahead. Ready to elevate your compliance standards? Let's connect!?? #ComplianceMatters #GMP #PreInspectionReadiness #Zenovel #AuditExcellence #QualityAssurance #Pharmaceuticals #Innovation
-
-
??Are You Inspection-Ready??? Ensuring compliance is non-negotiable in today’s highly regulated pharmaceutical landscape. Recently, ZENOVEL partnered with a valued client to conduct a comprehensive GMP Pre-Inspection Readiness Audit—a critical step in preparing for regulatory success. Our tailored approach went beyond the checklist: ? Identifying GAPs before they become findings ? Strengthening operational processes ? Ensuring robust compliance with regulatory standards ??Inspection readiness audits are your first line of defence against non-compliance. Whether it’s GMP, GCP, or other regulatory frameworks, ZENOVEL ensures you're always a step ahead. Ready to elevate your compliance standards? Let's connect!?? #ComplianceMatters #GMP #PreInspectionReadiness #Zenovel #AuditExcellence #QualityAssurance #Pharmaceuticals #Innovation
-
-
How is bioequivalence typically assessed??? Bioequivalence is essential for ensuring the safety, efficacy, and quality of pharmaceutical products. Regulatory guidelines like M13A outline specific methods to evaluate whether a drug performs similarly to its reference counterpart. Which method do you think is most commonly used? Cast your vote below! #Bioequivalence #Pharmacokinetics #DrugDevelopment #ClinicalResearch #RegulatoryAffairs #PharmaInnovation #M13A #PharmaceuticalStudies
此处无法显示此内容
在领英 APP 中访问此内容等
-
Achieve seamless GCP compliance with ZENOVEL! Our dedicated team provides comprehensive system audits and tailored compliance support, ensuring your facility stays audit-ready and meets the highest standards in clinical research. Let Zenovel help you build trust, quality, and efficiency into every step of your operations. ? #GCPCompliance #ClinicalResearch #Zenovel #PharmaSolutions #AuditReady #QualityStandards #RegulatoryExcellence
-
Sharing key takeaways from the FDA's M13A Bioequivalence Guidance. This comprehensive guideline outlines the principles for conducting bioequivalence studies for immediate-release solid oral dosage forms. Let's explore how this impacts drug development and regulatory approval processes. #generics #GCP #clinicalresearch #BE #clinicalstudies #Zenovel #innovation
-
??Are You Up-to-Date on the FDA’s M13A Bioequivalence Guidance??? Check your understanding and stay up-to-date on bioequivalence standards! #FDA #PharmaCompliance #Bioequivalence #RegulatoryGuidelines
此处无法显示此内容
在领英 APP 中访问此内容等
-
?? ZENOVEL at CPHI India 2024! ?? We’re excited to join CPHI India from November 26th-28th, showcasing our strengths in GCP Audit & Monitoring, GMP Audit & Consulting, and Global Regulatory Affairs Support. Connect with our team to discover how Zenovel can elevate your pharmaceutical business with industry-leading regulatory and compliance solutions. Let’s connect at?#CPHIINDIA2024!
-