🇮🇳 Bioavailability & Bioequivalence (BA/BE) Studies Services for Ankleshwar
CDSCO-Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides complete Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling tailored for pharmaceutical companies based in Ankleshwar, one of India’s largest API and formulation manufacturing zones.
All studies are fully compliant with:
CDSCO (Central Drugs Standard Control Organization)
New Drugs & Clinical Trials Rules, 2019
ICH GCP & WHO TRS
GLP & ICMR guidelines
Our services support DCGI submissions as well as international regulatory filings for export-driven companies.
💊 Core Services for Ankleshwar-Based Pharma Companies
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose & multiple-dose BE studies (crossover/parallel).
• Volunteer Recruitment: Healthy volunteers or patient groups as required.
• Ethics Approval: IEC approval through CDSCO-registered Ethics Committees.
• Protocol Development: Aligns with ICH E6 (R2), WHO TRS, and CDSCO expectations.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Mandatory for generic submissions, FDC approvals, and formulation changes.
• Dissolution Media: Biorelevant & pharmacopoeial (USP/IP) media.
• Similarity Evaluation: f2 similarity factor calculation.
• Advanced Modeling: Model-independent (f1, f2) & model-dependent analysis.
IVIVC & Biowaiver Support
• BCS-Based Biowaivers: Prepared as per CDSCO, ICH Q6A, and WHO TRS guidance.
• IVIVC Models: Level A, B, and C correlations for predictive BE justification.
• PK Prediction: Supports waiver requests and regulatory strategy planning.
Analytical Method Development & Validation
• Technologies: LC-MS/MS, HPLC-UV, and stability-indicating methods.
• Validation: According to ICH M10 and CDSCO bioanalytical norms.
• Stability Studies: For APIs and drug products per Indian guidelines.
Pharmacokinetic (PK) & Statistical Evaluation
• PK Approach: Non-compartmental analysis (NCA).
• BE Statistics: Follows Indian and international BE acceptance criteria.
• Sample Size Optimization: Based on power analysis & variability.
📑 CDSCO-Ready Documentation for Ankleshwar Manufacturers
We prepare regulatory documentation compliant with Indian submission requirements:
• Clinical Study Protocol
• Informed Consent Forms (ICF)
• Investigator Brochure
• Clinical Study Report (CSR) aligned with CDSCO
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules (1–5) for Form 44 submissions
✨ Why Choose BioEquiGlobal for Ankleshwar?
• Specialized for Manufacturing Clusters: Expertise in supporting companies located within Ankleshwar GIDC, India’s largest chemical & API belt.
• Regulatory Accuracy: All study designs & documentation aligned with NDCTR, 2019 and CDSCO protocols.
• Quality Infrastructure: Access to NABL-certified analytical labs and accredited clinical research facilities.
• Export-Ready Dossier Support: Packages prepared for regulated & semi-regulated markets, including USFDA, EMA, MHRA, TGA, GCC, WHO PQ, and others.
• Efficient Support: Ideal for API manufacturers transitioning into formulation development or ANDA/CTD submissions.
🗺️ BA/BE Study Workflow for Ankleshwar-Based Sponsors
Feasibility & Regulatory Assessment
(Reference product availability, biowaiver eligibility & CDSCO compliance check)Protocol Development & Ethics Approval
(Submission to CDSCO-registered IEC)Analytical Method Development
(Assay validation using LC-MS/MS per ICH M10)Clinical Study Execution
(GCP-compliant dosing, sampling, and safety monitoring)Bioanalysis & PK Evaluation
(BE statistics & PK modeling)Documentation & Submission
(CSR, CDP report, validation documents & CTD modules)
Who We Support in Ankleshwar
• API & bulk drug manufacturers entering formulations
• Generic drug manufacturers
• CROs & bioanalytical laboratories
• Regulatory & formulation development teams targeting Indian or export markets