🇮🇳 Bioavailability & Bioequivalence (BA/BE) Studies Services in Ahmedabad

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, serving pharmaceutical companies in Ahmedabad, Gujarat — one of India’s largest pharma and CRO hubs.

All studies comply with:

• CDSCO (Central Drugs Standard Control Organization)

• ICMR & ICH GCP Guidelines

• WHO TRS

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

• GLP-compliant analytical requirements

Our services support regulatory submissions for India (CDSCO/DCGI) as well as global markets.

💊 Core BA/BE Services for Ahmedabad-Based Pharma Companies & CROs

Clinical BA/BE Studies (Human)

• Study Designs: Single-dose & multiple-dose studies; crossover/parallel designs.
• Volunteer Recruitment: Healthy volunteers or patient studies as per protocol needs.
• Ethics Approval: IEC approval from registered Ethics Committees in Ahmedabad.
• Protocol Development: Aligned with CDSCO, ICH E6 (R2), and WHO TRS guidelines.

Comparative Dissolution Profiling (CDP)

• Regulatory Need: Mandatory for CDSCO submissions (Form 44, generic approvals, FDC filings).
• Dissolution Media: Biorelevant & pharmacopoeial media.
• Similarity Factor: f2 analysis for comparing test vs. reference dissolution profiles.
• Evaluation Models: Model-independent & model-dependent dissolution comparisons.

IVIVC & Biowaiver Support

• BCS-Based Biowaiver: Prepared following CDSCO/ICH Q6A & WHO TRS guidelines.
• IVIVC Modeling: Level A, B, and C correlation.
• Predictive Tools: Pharmacokinetic prediction & dissolution-PK mapping.

Analytical Method Development & Validation

• Platforms: LC-MS/MS, HPLC-UV, and stability-indicating methods.
• Validation: As per ICH M10 and CDSCO bioanalytical method validation norms.
• Stability Studies: API & formulation stability assessment per Indian guidelines.

Pharmacokinetic (PK) Analysis

• NCA Analysis: Non-compartmental PK evaluation using validated software.
• BE Statistics: 90% CI compliance for BE acceptance criteria.
• Study Design Optimization: Power analysis & sample-size justification.

📑 CDSCO-Compliant Documentation – Tailored for Ahmedabad Submissions

We prepare complete regulatory packages for India-specific filings:

• Clinical Study Protocol
• Informed Consent Forms (ICF)
• Investigator Brochure
• Clinical Study Report (CSR) aligned with CDSCO
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules for DCGI submissions (Form 44)

✨ Why Choose BioEquiGlobal for Ahmedabad?

• Strategic Location: Supporting Ahmedabad’s growing pharma ecosystem (API manufacturers, formulation units, CROs).
• Regulatory Expertise: Deep understanding of CDSCO & NDCTR, 2019 compliance.
• Quality-Focused Operations: GCP, GLP, ICH-aligned SOPs and internal QA audit systems.
• State-of-the-Art Infrastructure: Access to NABL-certified labs, validated bioanalytical platforms, and accredited clinical units.
• Global Reach: Expertise in dossiers for USFDA, EMA, MHRA, TGA, COFEPRIS, Health Canada, and others.

🗺️ Our BA/BE Workflow for Ahmedabad-Based Sponsors

1. Feasibility & Regulatory Assessment
   (Reference product availability, CDSCO gap analysis, biowaiver eligibility)

2. Protocol Development & Ethics Submission
   (IEC approval from Ahmedabad-based Ethics Committees)

3. Analytical Method Development
   (LC-MS/MS/HPLC validation per ICH M10)

4. Clinical Study Execution
   (Volunteer recruitment, dosing, sampling, monitoring, safety management)

5. Bioanalysis & PK/Statistical Evaluation
   (PK modeling and BE assessment)

6. CDSCO-Ready Documentation
   (CSR, CDP, validation reports & CTD modules)

Who We Support in Ahmedabad

• Generic formulation manufacturers
• CROs and bioanalytical labs
• Pharmaceutical R&D & regulatory teams
• Export-oriented formulation & API companies
• Start-ups entering regulated markets