Precision in Every Data Point
Safety in Every Life
A purpose-built 107-bed clinical pharmacology unit in Thaltej, Ahmedabad, delivering high-sensitivity LC-MS/MS bioanalysis and fully compliant BA/BE studies for pharmaceutical sponsors worldwide.
Scientific Excellence
Engineered for Trust
Integrity
Scientific honesty and complete transparency in every study, with zero tolerance for data compromise.
Innovation
Advanced high-sensitivity LC-MS/MS methodologies that enable precise quantification of challenging molecules at sub-picogram levels.
Quality
Independent Quality Assurance with rigorous risk-based audits, full ALCOA+ data integrity, and SOP governance across all phases.
Participant Safety
Continuous 24×7 medical oversight by ACLS/BLS-certified physicians and nursing staff, ensuring the highest level of volunteer safety.
World-Class Infrastructure
Clinical & Bioanalytical Excellence
107-Bed Clinical Pharmacology Unit
A modern, single-site CPU approved by the Central Drug Standard Control Organization (CDSCO) for conducting clinical studies, optimized for parallel BA/BE studies without cross-contamination risk.
- Clinic 1: 54 beds | Clinic 2A: 25 beds | Clinic 2B: 28 beds
- 24×7 ACLS-certified medical and nursing supervision
- Biometric access control and dual power backup
Advanced LC-MS/MS Platforms
High-throughput bioanalysis with exceptional sensitivity and reproducibility for complex molecules.
- Triple-quadrupole mass spectrometers supporting MRM analysis
- Validated −70°C storage with continuous temperature monitoring
- Light-protected areas for photosensitive compounds
Integrated Capabilities
Three specialized departments operate in seamless coordination to deliver end-to-end BA/BE services — from protocol design through regulatory submission — with uncompromising quality.
Clinical Pharmacology Unit
107 beds across three segregated clinics, purpose-designed for efficient, contamination-free parallel study execution under 24×7 physician oversight and strict access controls.
CPU · 107 BedsBioanalytical Department
Cutting-edge LC-MS/MS instrumentation delivering sub-pg/mL sensitivity for small molecules, endogenous compounds, and unstable analytes, supported by ICH M10-compliant validation.
LC-MS/MS · ICH M10Quality Assurance
Fully independent QA function enforcing ALCOA+ principles, risk-based monitoring, and rigorous SOP governance to ensure data integrity and zero critical audit findings.
GLP · GCP · ALCOA+Comprehensive BA/BE Services
End-to-end support for global pharmaceutical sponsors seeking reliable, regulator-ready data for generic and complex generic approvals.
Bioequivalence Studies
Healthy-volunteer BA/BE and comparative bioavailability studies conducted in full compliance with CDSCO, USFDA, Health Canada, and EMA requirements, including complex generics and special formulations.
Pharmacokinetic Analysis & Reporting
Expert non-compartmental and compartmental PK modeling using Phoenix WinNonlin, together with comprehensive biostatistics, data management, and eCTD-ready clinical study reports.
Regulatory Submission Support
Full regulatory affairs services, including protocol development, agency liaison, query response management, and preparation of submission dossiers for ANDA, ANDS/NDS, and equivalent pathways.
Build Your Future at India’s Focused BA/BE CRO
Join a focused research environment where clinical operations, bioanalysis, quality, and regulatory teams work together on studies built for precision and compliance.
Share Your Profile Directly With Our Hiring Team
Upload your CV or resume for current and upcoming opportunities. Suitable profiles will be reviewed by the Nexcellife team and routed to the relevant department.
CV Received
Thank you. Your CV has been sent to chintan.dholakia@nexcellife.com.
Our Headquarter
Strategically situated in Thaltej, Ahmedabad — within Gujarat’s dynamic life-sciences corridor — with excellent connectivity to major hospitals, research institutions, and international airports.
FP 100, TP 37,
opp. Jalaram kanya chhtralaya,
near TAKSHASHILA APARTMENT, Thaltej,
Ahmedabad, Gujarat 380059