🇮🇳 Bioavailability & Bioequivalence (BA/BE) Studies Services for Vadodara
CDSCO-Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, delivers comprehensive Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling to support pharmaceutical companies, CROs, analytical labs, and biotech units in Vadodara, a leading centre for formulation development, chemical research, and pharmaceutical manufacturing.
All studies comply with:
CDSCO (Central Drugs Standard Control Organization)
New Drugs & Clinical Trials Rules (NDCTR), 2019
ICH GCP & GLP
WHO Technical Report Series (TRS)
ICMR Ethical Guidelines
We support domestic regulatory submissions to CDSCO/DCGI, as well as international filings for USFDA, EMA, MHRA, TGA, Health Canada, and other agencies.
💊 Core BA/BE Services for Vadodara’s Pharma, CRO & R&D Ecosystem
Clinical BA/BE Studies (Human)
• Single-dose & multiple-dose BE study designs (crossover & parallel).
• Healthy volunteer and patient-based clinical studies.
• IEC approval via CDSCO-registered Ethics Committees in Gujarat.
• Protocols developed in alignment with ICH E6 (R2), WHO TRS & CDSCO guidelines.
Comparative Dissolution Profiling (CDP)
• Required for Form 44 submissions, FDC approvals, and formulation modifications.
• Dissolution studies conducted using IP/USP/EP & biorelevant media.
• f2 similarity factor to assess dissolution comparability.
• Model-independent & model-dependent dissolution evaluation.
IVIVC & Biowaiver Support
• BCS-based biowaiver justifications as per CDSCO, ICH Q6A, and WHO TRS.
• Level A/B/C IVIVC modeling for predictive PK estimation.
• Supports waiver of in vivo BE studies when scientifically justified.
Analytical Method Development & Validation
• LC-MS/MS, HPLC-UV, and stability-indicating analytical methods.
• Method validation as per ICH M10 and CDSCO bioanalytical expectations.
• Stability studies for APIs and finished dosage forms.
Pharmacokinetic (PK) & BE Statistical Analysis
• Non-compartmental PK analysis (NCA).
• BE statistical evaluation using the 90% CI acceptance criteria.
• Sample-size & power calculation for regulatory compliance.
📑 CDSCO-Compliant Documentation for Vadodara Submissions
We prepare complete submission-ready documentation, including:
• Clinical Study Protocol
• Informed Consent Forms (ICF)
• Investigator Brochure
• Clinical Study Report (CSR) as per CDSCO & ICH E3
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules (1–5) for domestic & international filings
✨ Why Choose BioEquiGlobal for Vadodara?
• Major Pharma & Chemical Hub: Vadodara houses many formulation units, API manufacturers, and R&D labs requiring BE support.
• Regulatory Expertise: Deep understanding of NDCTR & CDSCO guidelines and export regulatory expectations.
• Robust Infrastructure: Easy access to NABL-certified analytical labs and accredited clinical study centres.
• Export Market Advantage: Specialised in ANDA, CTD, eCTD dossier preparation for global markets.
• Full-Service Capability: From dissolution development to PK/BE analysis and submission.
🗺️ BA/BE Study Workflow for Vadodara Sponsors
Feasibility & Regulatory Assessment
(Reference product availability, biowaiver feasibility, CDSCO gap analysis)Protocol Development & IEC Approval
(Ethics submission via Gujarat/NCR-based committees)Analytical Method Development & Validation
(LC-MS/MS validation as per ICH M10)Clinical Study Execution
(Volunteer recruitment, dosing, PK sampling & GCP-compliant monitoring)Bioanalysis & PK/BE Evaluation
(PK modeling, QC checks & BE statistical evaluation)Final Documentation & Submission
(CSR, CDP, validation dataset & CTD modules)
Who We Support in Vadodara
• Formulation & API manufacturers
• CROs & bioanalytical laboratories
• Pharmaceutical R&D centres
• Quality control & quality assurance units
• Contract manufacturing organizations (CMOs)
• Export-oriented pharma companies targeting regulated markets