🇮🇳 Bioavailability & Bioequivalence (BA/BE) Studies Services for Vapi

CDSCO-Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides end-to-end Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling for pharmaceutical companies in Vapi, Gujarat — a major centre for bulk drugs, API manufacturing, and formulation development.

The Vapi–Silvassa–Daman industrial zone hosts hundreds of pharma companies engaged in domestic and export markets, making reliable BA/BE services essential for regulatory submissions.

All studies comply with:

• CDSCO (Central Drugs Standard Control Organization)

• New Drugs & Clinical Trials Rules (NDCTR), 2019

• ICH GCP & WHO TRS

• GLP standards

• ICMR Ethical Guidelines

We support CDSCO/DCGI submissions, as well as global regulatory filings for USFDA, EMA, MHRA, TGA, Health Canada, and others.

💊 Core BA/BE Services for Vapi’s Pharma, API & Chemical Sector

Clinical BA/BE Studies (Human)

• BE designs: Single-dose & multiple-dose (crossover & parallel).
• Healthy volunteer & patient-based studies as required.
• IEC approvals via CDSCO-registered Ethics Committees in Gujarat/Mumbai.
• Protocol development in compliance with ICH E6 (R2), WHO TRS & CDSCO guidelines.

Comparative Dissolution Profiling (CDP)

• Required for generic product filings, Form 44, and FDC approvals.
• Dissolution studies using IP/USP/EP pharmacopoeial & biorelevant media.
• f2 similarity factor calculation for profile comparison.
• Model-dependent & model-independent dissolution analysis.

IVIVC & Biowaiver Support

• BCS-based biowaiver justification following CDSCO, ICH Q6A, and WHO TRS.
• Level A/B/C IVIVC modeling for predictive PK correlation.
• Supports waiver of in vivo studies where scientifically justified.

Analytical Method Development & Validation

• LC-MS/MS & HPLC-UV bioanalytical method development.
• Validation according to ICH M10 & CDSCO bioanalytical norms.
• Stability-indicating methods for APIs and finished products.

Pharmacokinetic (PK) & BE Statistical Evaluation

• Non-compartmental PK analysis (NCA).
• BE assessment using standard 90% CI regulatory acceptance criteria.
• Sample-size & power calculation based on PK variability.

📑 CDSCO-Compliant Documentation for Vapi Submissions

We prepare complete submission-ready documentation packages:

• Clinical Study Protocol
• Informed Consent Form (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 domestic & international submissions

✨ Why Choose BioEquiGlobal for Vapi?

• India’s Largest Chemical & API Belt: Vapi–Silvassa–Daman zone is home to bulk drug & formulation units needing BE support.
• Export-Ready Expertise: Specialized in dossier preparation for ANDA, CTD, and international submissions.
• Regulatory Alignment: Deep knowledge of NDCTR, CDSCO expectations, and global regulatory standards.
• Infrastructure Advantage: Access to NABL-certified analytical labs & accredited clinical trial centres.
• Ideal for SMEs & Large Manufacturers: Flexible engagement for companies preparing for regulated markets.

🗺️ BA/BE Study Workflow for Vapi Sponsors

1. Feasibility & Regulatory Strategy
   (Reference product identification, CDSCO gap assessment & biowaiver eligibility)

2. Protocol Development & IEC Approval
   (Ethics submission via Gujarat/Mumbai-based ethics committees)

3. Analytical Method Development & Validation
   (LC-MS/MS assays validated as per ICH M10)

4. Clinical Study Execution
   (Volunteer recruitment, dosing, PK sampling & safety monitoring under GCP)

5. Bioanalysis & PK/BE Interpretation
   (PK modeling, QC verification & BE statistical analysis)

6. Final Documentation & Submission
   (CSR, CDP report, validation package & CTD modules)

Who We Support in Vapi

• API & bulk drug manufacturers
• Formulation development & generic drug companies
• CROs & bioanalytical laboratories
• Chemical & pharma intermediate manufacturers transitioning to formulations
• Export-focused pharmaceutical units
• Start-ups entering regulated markets