🇮🇳 Bioavailability & Bioequivalence (BA/BE) Studies Services for India
CDSCO-Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, offers complete Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling services tailored to the requirements of the Central Drugs Standard Control Organization (CDSCO), Government of India.
All our studies strictly follow GCP, GLP, ICH, WHO TRS, and New Drugs & Clinical Trials Rules (NDCTR), 2019, ensuring full compliance for Indian regulatory submissions and international markets.
💊 Core Services for CDSCO Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose studies; crossover and parallel designs.
• Volunteer Selection: Healthy volunteer and patient-based studies as per CDSCO requirements.
• Ethics Approval: IEC (Institutional Ethics Committee) approval as mandated by NDCTR 2019.
• Protocol Compliance: Protocols aligned with CDSCO, ICH E6 (R2), and WHO TRS guidance.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Essential for generic drug applications and fixed-dose combination approvals under CDSCO guidelines.
• Media Selection: Biorelevant and pharmacopeial dissolution media.
• Similarity Assessment: f2 similarity factor calculation for comparison of test and reference dissolution profiles.
• Dissolution Evaluation: Model-independent (f1, f2) and model-dependent methods.
IVIVC & Biowaiver Support
• BCS Biowaiver: Preparation of biowaiver justification as per CDSCO, WHO TRS, and ICH Q6A guidelines.
• IVIVC Modeling: Level A, B, and C in vitro–in vivo correlation modeling.
• Predictive PK Modeling: Linking dissolution data with pharmacokinetic performance.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV analytical methods for drug quantification.
• Validation: Conducted as per ICH M10 and CDSCO bioanalytical method guidelines.
• Stability Studies: Development of stability-indicating methods for APIs and drug products.
Pharmacokinetic (PK) Analysis
• PK Modeling: Non-compartmental PK analysis for all dosage forms.
• BE Statistics: Statistical analysis for bioequivalence using internationally accepted methodologies.
• Sample Size Calculation: Power analysis and study design optimization per CDSCO norms.
📑 CDSCO-Ready Regulatory Documentation
We prepare all documentation required for DCGI/CDSCO submissions, including:
• Clinical Study Protocol
• Informed Consent Forms (ICF)
• Investigator Brochure
• Clinical Study Report (CSR) in CDSCO format
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules for Form 44 and other regulatory submissions
✨ Why Choose BioEquiGlobal for India?
• CDSCO-Focused Expertise: Protocols and documentation aligned with India's latest regulatory framework (NDCTR 2019).
• Quality & Compliance: Internal QA audits, SOP-driven operations, adherence to GCP & GLP standards.
• Advanced Infrastructure: Accredited clinical facilities and NABL-certified analytical labs (where applicable).
• Global Dossier Capability: Dossiers prepared for CDSCO, as well as US FDA, EMA, MHRA, GCC, TGA, and other international agencies.
🗺️ BA/BE Study Workflow for India
Feasibility & Gap Assessment: Review of reference product, Indian market benchmarks, and biowaiver eligibility.
Protocol Development: CDSCO-compliant BA/BE protocol creation and IEC approval.
Analytical Method Development: LC-MS/MS method design and validation as per ICH M10.
Clinical Study Execution: Volunteer recruitment, dosing, and sampling under strict GCP monitoring.
Bioanalysis & PK Evaluation: PK computation, QC verification, and statistical BE assessment.
Documentation & Submission: Preparation of CDSCO-ready CSR, validation reports, dissolution profile, and CTD/ACTD modules.
Who We Support
• Indian pharmaceutical manufacturers targeting CDSCO submissions and global markets
• CROs requiring advanced BA/BE or analytical outsourcing
• Regulatory teams needing CDSCO-compliant CTD/ACTD documentation