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

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 manufacturers, CROs, R&D centers, and bioanalytical laboratories located in Indore, a key pharmaceutical and industrial powerhouse of Central India.

All services 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 regulatory submissions for CDSCO, as well as global regulatory agencies like USFDA, EMA, MHRA, TGA, Health Canada, and others.

💊 Core BA/BE Services for Indore’s Pharma & CRO Sector

Clinical BA/BE Studies (Human)

• Single-dose & multiple-dose BE studies (crossover or parallel).
• Healthy volunteer & patient-based BE studies as per drug requirements.
• IEC approvals through CDSCO-registered Ethics Committees in Indore.
• BE protocols designed per ICH E6 (R2), WHO TRS & CDSCO standards.

Comparative Dissolution Profiling (CDP)

• Required for Form 44 filings, generic drug development, and FDC approvals.
• Pharmacopoeial (IP/USP/EP) & biorelevant dissolution media.
• f2 similarity factor for comparing dissolution curves.
• Model-independent & model-dependent dissolution evaluations.

IVIVC & Biowaiver Support

• BCS-based biowaiver preparation as per CDSCO, ICH Q6A, and WHO TRS guidelines.
• Level A/B/C IVIVC models to establish in vitro–in vivo correlation.
• PK-predictive modeling for regulatory justification and study optimization.

Analytical Method Development & Validation

• Advanced LC-MS/MS and HPLC-UV platforms.
• Validation as per ICH M10 and CDSCO bioanalytical expectations.
• Stability-indicating methods for APIs & finished dosage forms.

Pharmacokinetic (PK) & BE Statistical Evaluation

• Non-compartmental PK analysis (NCA).
• 90% CI–based BE evaluation as per CDSCO norms.
• Power & sample-size calculation to ensure optimal study design.

📑 CDSCO-Compliant Documentation for Indore-Based Sponsors

We prepare end-to-end regulatory documentation, including:

• 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) ready for Form 44 or export submissions

✨ Why Choose BioEquiGlobal for Indore?

• Pharma Manufacturing Hub: Indore hosts SEZs, formulation plants, API units, and R&D centers — ideal for integrated BE support.
• Strong CRO Ecosystem: Access to experienced clinical units & bioanalytical labs in and around Indore.
• Regulatory Expertise: Deep familiarity with NDCTR, CDSCO BE expectations, and international dossier requirements.
• Modern Infrastructure: NABL-certified analytical labs and accredited clinical study facilities.
• Export-Ready Support: Expertise in ANDA, CTD, eCTD preparation for regulated markets.

🗺️ BA/BE Study Workflow for Indore Sponsors

1. Feasibility & Regulatory Assessment
   (Reference product study feasibility, DSCOS gap review, biowaiver evaluation)

2. Protocol Development & IEC Approval
   (Ethics submission through Indore-based IECs)

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

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

5. Bioanalysis & PK/BE Interpretation
   (PK modeling, QC checks, and BE statistical evaluation)

6. Documentation & Submission
   (CSR, CDP, validation documents & CTD modules)

Who We Support in Indore

• Formulation & generic drug manufacturers
• CROs, clinical research units & hospitals
• Bioanalytical laboratories
• R&D and formulation development teams
• Export-oriented pharmaceutical companies
• Start-ups entering regulated markets