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

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 to support pharmaceutical companies operating in Visakhapatnam, a major Indian hub for bulk drug production, formulation manufacturing, and export-driven pharma operations.

Vizag’s Pharma City (JNPC, Parawada) and nearby industrial estates host leading API & formulation units, making regulatory-compliant BA/BE studies essential for domestic & international approvals.

All studies follow:

• CDSCO (Central Drugs Standard Control Organization)

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

• ICH GCP & WHO TRS

• GLP-certified analytical procedures

• ICMR Ethical Guidelines

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

💊 Core BA/BE Services for Visakhapatnam’s Pharma, API & CRO Sector

Clinical BA/BE Studies (Human)

• Crossover & parallel BE study designs (single-dose & multiple-dose).
• Healthy volunteer & patient-based studies depending on therapeutic class.
• IEC approval through CDSCO-certified ethics committees in Vizag & neighbouring regions.
• Protocol development aligned with ICH E6 (R2), CDSCO guidelines & WHO TRS.

Comparative Dissolution Profiling (CDP)

• Required for Form 44 filings, generic approvals, FDC applications, and formulation changes.
• Dissolution studies in IP/USP/EP & biorelevant media (FaSSIF, FeSSIF).
• f2 similarity factor evaluation for dissolution comparability.
• Model-independent & model-dependent dissolution analysis techniques.

IVIVC & Biowaiver Support

• BCS-based biowaiver preparation as per CDSCO, ICH Q6A, and WHO TRS.
• Level A, B & C IVIVC models for predictive PK correlation.
• Supports in vivo BE waiver where scientifically justified.

Analytical Method Development & Validation

• LC-MS/MS & HPLC-UV platforms for sensitive and specific bioanalysis.
• Bioanalytical validation as per ICH M10 & CDSCO regulatory standards.
• Stability-indicating methods for APIs & finished dosage forms.

Pharmacokinetic (PK) & BE Statistical Evaluation

• Non-compartmental PK analysis (NCA).
• BE evaluation using 90% confidence interval acceptance limits.
• Power & sample-size calculations for study optimization.

📑 CDSCO-Compliant Documentation for Visakhapatnam Submissions

We prepare comprehensive documentation required for India and global filings:

• Clinical Study Protocol
• Informed Consent Form (ICF)
• Investigator Brochure
• Clinical Study Report (CSR) per CDSCO & ICH E3 guidelines
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules (1–5) for Form 44 and international submissions

✨ Why Choose BioEquiGlobal for Visakhapatnam?

• India’s Leading Bulk Drug & Formulation Hub: Vizag Pharma City hosts numerous API and formulation plants supplying global markets.
• Export-Ready Expertise: Ideal for companies preparing for ANDA, CTD, and eCTD submissions.
• Regulatory Strength: Deep understanding of CDSCO, NDCTR, and global regulatory frameworks.
• Advanced Infrastructure Access: Proximity to NABL-certified analytical labs & accredited BA/BE clinical study centres.
• End-to-End Scientific Support: From dissolution development to full clinical BE execution and documentation.

🗺️ BA/BE Study Workflow for Visakhapatnam Sponsors

1. Feasibility & CDSCO Regulatory Assessment
   (Reference product identification, biowaiver feasibility & regulatory pathway mapping)

2. Protocol Development & IEC Approval
   (Ethics submission to approved IECs in Vizag/Andhra region)

3. Analytical Method Development & Validation
   (LC-MS/MS method development per ICH M10)

4. Clinical Execution of BA/BE Studies
   (Volunteer recruitment, dosing, PK sampling & GCP-compliant monitoring)

5. Bioanalysis & PK/BE Evaluation
   (PK modeling, QC verification & BE statistical interpretation)

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

Who We Support in Visakhapatnam

• API manufacturers & bulk drug producers
• Formulation development & generic drug units
• CROs & bioanalytical laboratories
• Pharmaceutical R&D centres
• Export-oriented pharma companies
• Start-ups entering regulated markets