Drug reformulation breathes new life into existing molecules by addressing limitations related to solubility, stability, bioavailability, patient compliance, or market differentiation.
At EndraBio, our clinical team comprises highly skilled professionals — including doctors, pharmacologists, pharmacists, and science graduates — with extensive experience in conducting Bioavailability and Bioequivalence (BA/BE) studies.
Single-dose (Fast/Fed/Sprinkled applesauce)
Multiple-dose (Fast/Fed)
Steady-state and replicate design studies
Parallel and truncated BA/BE studies
Controlled psychotropic substance studies
Comparative BA studies (505(b)(2) submissions)
Food-effect, PK/PD, and drug-drug interaction studies
BA/BE studies in patient populations
Enteral: Oral, Sublingual, Rectal
Parenteral: Intravascular, Intramuscular, Subcutaneous, Inhalation
Topical: Creams, Lotions, Gels, Patches
Vaginal and Rectal: Suppositories, Enemas
Special Population Studies
Post-menopausal women
Geriatric subjects
Hypogonadal male subjects
EndraBio houses a state-of-the-art Bioanalytical Research Department, led by experienced scientists and supported by a highly skilled technical team. Our facility provides specialized analytical services to support drug developers in optimizing drug candidates, ensuring safety and efficacy, and meeting global regulatory standards.
Dedicated 4000 sq. ft. bioanalytical lab housed in a separate building
Two LC-MS/MS Systems (SCIEX 4500) for accurate and sensitive analysis
Audit trail and advanced data security systems for traceability and integrity
Sample preparation lab equipped with centrifuges, SPE manifolds, refrigerators, vortex mixers, pH meter, ultrasonic bath, nitrogen evaporator, and fume hoods (restricted access)
Mettler Toledo Micro/Analytical balance for precise measurements
Method development and validation (MD/MV) of simple and complex drugs and metabolites as per regulatory standards
GLP and 21 CFR Part 11 compliant facility
Deep Freezers (-70°C ×2) and Freezer (-20°C ×1) for secure sample storage
Separate pharmaceutical refrigerators for working/reference standards and stock solutions
Centralized temperature monitoring system for controlled environments
At EndraBio, we deliver end-to-end clinical trial solutions from Phase I to Phase IV, leveraging our global network of clinical trial sites.
Our Clinical Trial Capabilities
1. Site Feasibility & Identification
We select the most suitable sites to ensure optimal patient recruitment, trial efficiency, and high-quality data.
2. Clinical Trial Management
Our expert team oversees every aspect of the trial process — maintaining timelines, adherence to protocols, and seamless coordination.
3. Operations & Monitoring
Comprehensive on-site and remote monitoring ensures data integrity, patient safety, and compliance with regulatory standards.
4. Medical Monitoring
Our experienced medical professionals provide ongoing safety oversight, manage adverse events, and uphold trial integrity.
5. Medical & Scientific Writing
We create precise and compliant documentation — including study protocols, investigator brochures, clinical study reports, and regulatory submissions.
6. Project Management
Dedicated project managers coordinate teams, resources, and deliverables to ensure smooth project execution.
7. Biostatistics & Data Management
Our robust data management and statistical analysis processes ensure accurate, reliable, and regulatory-compliant reporting.
8. Quality Assurance
We implement rigorous GCP-aligned quality control systems to meet international regulatory requirements and maintain excellence at every stage.
Whether you’re developing next-generation therapies, optimizing your product pipeline, or scaling pharmaceutical operations—Endra Pharma is your trusted partner from strategy to supply.
Endra Pharma is USA based B2B services company having global partner network along with owned CDMO, CRO services and Lab network addressing need in product development.