🇮🇳 Bioavailability & Bioequivalence (BA/BE) Studies Services for Nashik
CDSCO-Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides comprehensive Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling tailored for pharmaceutical and healthcare companies based in Nashik, one of Maharashtra’s growing pharma & biotech manufacturing regions.
All studies strictly 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 regulatory submissions to CDSCO, and international agencies like USFDA, EMA, MHRA, TGA, Health Canada, and others.
💊 Core BA/BE Services for Nashik-Based Manufacturers, CROs & R&D Units
Clinical BA/BE Studies (Human)
• Single-dose & multiple-dose BE studies (crossover & parallel).
• Healthy volunteer & patient-group studies based on therapeutic needs.
• IEC approval through CDSCO-registered Ethics Committees.
• Protocol development per ICH E6 (R2), WHO TRS & CDSCO guidelines.
Comparative Dissolution Profiling (CDP)
• Required for generic filings, FDC approvals, and post-approval changes.
• Dissolution testing in pharmacopoeial (IP/USP/EP) & biorelevant media.
• f2 similarity factor calculation for dissolution equivalence.
• Model-independent & model-dependent dissolution analysis.
IVIVC & Biowaiver Support
• BCS-based biowaiver preparation as per CDSCO, WHO TRS, and ICH Q6A.
• Level A/B/C IVIVC correlation modeling.
• Dissolution–PK predictive modeling to support waiver strategies.
Analytical Method Development & Validation
• LC-MS/MS & HPLC-UV analytical platforms.
• Validation per ICH M10 and CDSCO bioanalytical guidelines.
• Stability-indicating methods for APIs & finished products.
Pharmacokinetic (PK) & BE Statistical Evaluation
• Non-compartmental PK analysis (NCA).
• BE evaluation using 90% CI acceptance criteria.
• Power & sample-size calculation for optimal study design.
📑 CDSCO-Ready Documentation for Nashik Submissions
We prepare complete regulatory documentation for domestic & export filings:
• Clinical Study Protocol
• Informed Consent Forms (ICF)
• Investigator Brochure
• Clinical Study Report (CSR) per CDSCO & ICH E3
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules (1–5) for Form 44 or international submissions
✨ Why Choose BioEquiGlobal for Nashik?
• Emerging Pharma Manufacturing Hub: Nashik hosts several formulation and API units, making it ideal for BE study integration.
• Proximity to Major Markets: Well connected to Mumbai & Pune for CRO, analytical, and clinical study support.
• Infrastructure Access: NABL-certified labs and accredited clinical research centres available in the region.
• Regulatory Expertise: Strong understanding of NDCTR, CDSCO guidelines, and international CTD requirements.
• Suitable for SMEs & Large Manufacturers: Supports both domestic and export-driven pharma businesses.
🗺️ BA/BE Study Workflow for Nashik Sponsors
Feasibility & Regulatory Assessment
(Reference product availability, CDSCO guideline mapping, biowaiver evaluation)Protocol Development & IEC Approval
(Ethics submission handled via approved committees)Analytical Method Development & Validation
(LC-MS/MS assay validation per ICH M10)Clinical Study Execution
(GCP-compliant recruitment, dosing, sampling & safety monitoring)Bioanalysis & PK/BE Interpretation
(PK modeling, QC checks & BE statistics)Final Documentation & Submission
(CSR, CDP report, validation package & CTD modules)
Who We Support in Nashik
• API & formulation manufacturers
• CROs & bioanalytical laboratories
• R&D centres & formulation development teams
• Hospital-based clinical research units
• Export-oriented pharmaceutical companies