Our Services
BA / BE Studies
Pudhu Lifescience provides specialized Bioavailability (BA) and Bioequivalence (BE) study services to support pharmaceutical companies in the development and approval of safe and effective medicines.
As a growing Clinical Research Organization (CRO), we assist pharmaceutical sponsors in conducting scientifically designed BA/BE studies that meet regulatory requirements and generate reliable pharmacokinetic data.
Our research-driven approach ensures that each study is conducted with precision, regulatory compliance, and ethical clinical practices.
Various Routes of Administration
- Injection (IM, IV, Subcutaneous)
- Oral (Tablets: IR,ER,SR,MR,CR,DR,ODT,Chewable)
- Rectal (Suppository & Foam)
- Transdermal (Patch, Topical Cream, Topical Gel, Lotion)
- Inhalation
- Vaginal (Tablet, Cream, Gel)
Clinical Set Up
- Clinical units, 60 beds, 2 ICU beds
- Healthy subject database
- Accredited Pathology Laboratory
Clinical Trial Management
Pudhu Lifescience provides professional Clinical Trial Management Services to support pharmaceutical and biotechnology companies in conducting safe, efficient, and regulatory-compliant clinical studies.
As a growing Clinical Research Organization (CRO), we assist sponsors throughout the clinical research process by coordinating investigators, managing study protocols, and ensuring accurate data collection. Our goal is to simplify complex clinical trials while maintaining the highest standards of scientific integrity, regulatory compliance, and patient safety.
Through structured study coordination and experienced leadership, Pudhu Lifescience helps pharmaceutical companies execute clinical trials efficiently and generate reliable clinical data required for regulatory approvals.
Our Clinical Trial Management Services
Study Planning & Protocol Coordination
We assist in planning clinical studies and coordinating research protocols to ensure that trials are conducted efficiently and according to scientific and regulatory requirements.
Investigator & Clinical Site Coordination
Our team works closely with investigators and research sites to ensure proper study execution, communication, and monitoring throughout the clinical trial process.
Participant Recruitment Support
Identifying and recruiting suitable study participants is essential for successful clinical trials. Pudhu Lifescience assists with participant identification and recruitment coordination.
Clinical Trial Monitoring
We support monitoring activities that ensure clinical trials follow approved protocols, maintain patient safety, and produce reliable clinical data.
Clinical Data Documentation & Reporting
Accurate documentation is essential in clinical research. Our team supports data collection, documentation, and reporting processes required for regulatory submissions.
Bioanalytical Lab
Pudhu Lifescience provides quality services for pharmacokinetic, immunogenicity, and large molecule analysis, leveraging a diverse array of platforms for both small and large molecule analysis. Our bioanalytical procedures adhere to GLP requirements, and we foster cross-functional team collaboration to ensure the swift analysis of time-critical samples.
Data Management
Accurate documentation and data management are critical components of clinical research.
During this phase, Pudhu Lifescience supports:
- Clinical data collection and verification
- Proper documentation of study procedures
- Maintenance of regulatory-compliant records
- Data integrity and traceability
Reliable data collection ensures that research results are accurate and suitable for regulatory submissions.
After study completion, collected data is analyzed and compiled into structured reports.
This stage includes:
- Analysis of clinical research data
- Preparation of study reports
- Maintenance of regulatory-compliant records
Proper data analysis and reporting provide pharmaceutical sponsors with valuable insights required for drug development and regulatory approvals.
Complex Products
We excel in conducting transdermal patch trials, dermatological treatments and glucose clamp studies that meet both regulatory and clinical requirements. Our services include adhesion studies, pharmacokinetic evaluations, and assessments of skin irritation under real-world conditions. With our expertise, your complex generic studies are in capable hands
PBPK & Modeling Solutions
Smart Drug Modeling for Better Clinical Decisions
At Pudhu Lifescience, we provide advanced PBPK (Physiologically Based Pharmacokinetic) modeling and biosimulation solutions to support efficient and data-driven drug development.
PBPK models integrate human physiology, disease conditions, and drug data to simulate how medicines behave in the body. This enables accurate prediction of drug exposure, safety, and efficacy across different populations and clinical scenarios.
Our solutions help in First-in-Human (FIH) dose selection, clinical strategy optimization, and risk reduction, ensuring faster and more reliable development outcomes.
Clinical Pharmacology
At Pudhu Lifescience, our Clinical Pharmacology expertise spans the entire drug development lifecycle—from preclinical pharmacology and PK/PD to clinical therapeutics. We focus on building a strong scientific foundation for drug use, development, and evaluation, where each stage adds value to the next.
We understand the complexities involved in translating pharmacological responses into measurable clinical outcomes. Factors such as trial design, pharmacokinetics, formulation, and patient variability play a critical role in determining drug efficacy and safety.
Our approach bridges the gap between scientific research and real-world clinical application, enabling better understanding of exposure-response relationships, biomarkers, and clinical outcomes. Our Capabilities includes:
- Translation of dose from animal to human
- Dose selection based on clinical data
- Dose optimization for Phase II & III trials
- Model-based extrapolation for sub-populations (Pediatric, Geriatric, Renal & Hepatic impairment)
- Assessment of population variability
- Time-course evaluation of drug response
- Drug characteristics vs. clinical outcomes
- Sub-population response evaluation
- Trial design based on safety and simulated exposures
- Patient selection and eligibility criteria
- Special studies: Renal, Hepatic, Pediatric, Radiolabeled
- Support for Biowaivers
Speciality Formulations
At Pudhu Lifescience, we provide smart, model-informed formulation strategies that integrate formulation characteristics, experimental data, pharmacokinetics, and regulatory pathways.
Our approach combines real-world experience with advanced biosimulations and mathematical modeling to support the design, development, and optimization of complex dosage forms. We help pharmaceutical companies accelerate product development while ensuring efficiency, compliance, and clinical success across global markets. We support the development of a wide range of formulations, including: Inhalation products, Novel Drug Delivery Systems (NDDS), Topical formulations, Solid and liquid oral dosage forms, Extended release Injectables and Ophthalmics products.
Our expertise enables faster development, optimization, clinical evaluation, and regulatory strategy planning.
- Dissolution modeling, In Vitro–In Vivo Correlation (IVIVC) development
- Establishing clinically relevant dissolution profiles
- Prediction of drug behavior across populations
- Optimization of formulation strategies
- Biowaivers support
- Formulation selection and optimization
- Dosage form modifications
- Design of trials for 505(b)(2) pathways
- Development strategies for NDDS and non-oral products
- Lifecycle management of pharmaceutical products
- Regulatory-focused formulation planning