Empowering Healthcare Through
CliniGenix delivers comprehensive healthcare research solutions—from bioanalytical testing and regulatory submissions to statistical analysis and clinical development. We combine scientific expertise with advanced technology to ensure data integrity, regulatory compliance, and successful project outcomes.
State-of-the-art clinical facility
Advanced analytical instruments
Full regulatory compliance
Our Core Services
We handle everything from BA/BE studies and bioanalysis to regulatory submissions and statistical analysis. Our goal is simple: help you get your drug approved faster while meeting all regulatory requirements.
Bioavailability and Bioequivalence (BA/BE)
We conduct BA/BE studies that help generic manufacturers prove their formulations work the same way as reference products in the human body.
Clinical Development Services
From first-in-human studies to post-marketing surveillance, we manage trials that bring new medicines from lab bench to patient bedside.
Bioanalytical
Our laboratory measures drug concentrations in blood samples using LC-MS/MS and other techniques to understand how medications behave in patients.
Medical Writing
Our writers prepare the scientific documents needed for regulatory submissions, from study protocols to final clinical study reports.
Project Management
We keep your clinical development program on track by coordinating teams, managing budgets, and solving problems before they cause delays.
Regulatory Services
We help you navigate CDSCO, USFDA, and other regulatory pathways to get your drug approved and marketed.
Bio Statistical Services
Our statisticians design studies, calculate sample sizes, and analyze trial data to answer whether your treatment actually works.
Pharmacovigilance
We monitor drug safety throughout clinical trials and post-marketing, tracking adverse events and ensuring patient protection.
Clinical Data Management
We design case report forms, build EDC databases, and ensure your clinical data is clean, accurate, and ready for analysis.
Central Laboratory
Our central lab processes clinical samples from trial sites, running standardized tests to ensure consistent, high-quality laboratory data.
Why Choose CliniGenix
Our core values drive everything we do. From empathy and innovation to quality and integrity, we're committed to delivering research excellence that makes a real difference.
Empathy and Dynamism
We understand the unique challenges you face in healthcare research. Our dynamic approach combines speed, creativity, and agility to deliver solutions tailored to your specific needs.
Quality & Compliance Excellence
Quality is designed into every system and process we build. From bioanalytical testing to regulatory submissions, we maintain the highest standards of safety, efficacy, and regulatory compliance.
Integrity & Transparency
We uphold the highest standards of integrity and transparency in all our interactions. You'll always know where your project stands with clear communication and honest reporting.
Innovation-Driven Solutions
In a field driven by data, constrained by time, and bound by regulatory compliance, innovation brings vast improvement. We continuously explore new methodologies to enhance efficiency and outcomes.
Experienced Multidisciplinary Team
Our professionals bring decades of combined expertise across bioanalytical sciences, clinical development, regulatory affairs, and statistical analysis to support your research goals.
Efficient and Timely Delivery
Streamlined processes and efficient resource allocation ensure your projects stay on track. We deliver exceptional value without compromising quality or timelines.
How We Work
Our streamlined process ensures efficient trial execution from concept to completion
Initial Consultation
We begin with a comprehensive discussion to understand your trial requirements, objectives, and regulatory needs.
Protocol Development
Our team develops detailed study protocols aligned with regulatory standards and your specific goals.
Site Selection & Setup
We identify and activate qualified research sites, ensuring proper training and resource allocation.
Trial Execution
Comprehensive monitoring and management throughout the trial lifecycle with real-time oversight.
Data Analysis
Rigorous statistical analysis and quality checks to ensure data integrity and regulatory compliance.
Regulatory Submission
Complete documentation and submission support for regulatory approvals and market authorization.
Let's Discuss Your Research Project
Partner with CliniGenix for comprehensive pharmaceutical and life sciences research solutions. Whether you need bioanalytical testing, regulatory support, statistical analysis, or end-to-end clinical development, our team is ready to guide your project from concept to completion.
Trusted by leading pharmaceutical and biotech organizations worldwide