🇮🇳 Bioavailability & Bioequivalence (BA/BE) Studies Services for Baddi
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 the massive pharmaceutical cluster of Baddi, Himachal Pradesh — home to India’s largest concentration of formulation manufacturing units.
All studies follow:
CDSCO (Central Drugs Standard Control Organization)
New Drugs & Clinical Trials Rules (NDCTR), 2019
ICH GCP & GLP
WHO TRS
ICMR Ethical Guidelines
We support regulatory submissions to CDSCO/DCGI and global markets (USFDA, EMA, TGA, MHRA, etc.).
💊 Core BA/BE Services for Baddi-Based Pharma Companies
Clinical BA/BE Studies (Human)
• Single-dose & multiple-dose BE studies (crossover/parallel).
• Healthy volunteer or patient-based studies depending on molecule complexity.
• IEC approval through CDSCO-registered Ethics Committees.
• Protocols aligned with ICH E6 (R2), WHO TRS & CDSCO advisories.
Comparative Dissolution Profiling (CDP)
• Required for generic applications, FDC approvals, and formulation changes.
• Dissolution Media: Pharmacopoeial (IP/USP) & biorelevant (FaSSIF/FeSSIF).
• f2 similarity factor for dissolution comparison.
• Model-independent and model-dependent dissolution assessments.
IVIVC & Biowaiver Support
• BCS-based biowaiver justification per CDSCO/ICH Q6A/WHO TRS.
• Level A, B, and C IVIVC models.
• Predictive PK modeling & dissolution–PK correlation.
Analytical Method Development & Validation
• LC-MS/MS & HPLC-UV bioanalytical platforms.
• Validation per ICH M10 and CDSCO bioanalytical requirements.
• Stability-indicating method development for API & finished dosage forms.
Pharmacokinetic (PK) & Statistical Analysis
• Non-compartmental PK analysis (NCA).
• BE assessment using 90% CI BE acceptance ranges.
• Sample size estimation based on variability, power & CDSCO guidelines.
📑 CDSCO-Ready Documentation for Baddi Manufacturers
We prepare the following India-specific regulatory documentation:
• Clinical Study Protocol
• Informed Consent Forms (ICF)
• Investigator Brochure
• Clinical Study Report (CSR) per CDSCO structure
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules (1–5) for New Drug/Form 44 submissions
✨ Why Choose BioEquiGlobal for Baddi?
• Deep Integration With the Baddi Pharma Ecosystem: Supporting formulation units, R&D centers, and contract manufacturers.
• CDSCO & NDCTR Compliance Expertise: Ensuring smooth audits, submissions, and regulatory acceptance.
• Quality Infrastructure: Access to NABL-certified analytical labs and accredited clinical study centers.
• Export-Ready Documentation: ANDA/CTD dossier preparation for global regulated & semi-regulated markets.
• End-to-End Support: From dissolution profiling to final regulatory submission.
🗺️ BA/BE Workflow for Baddi Pharma Companies
Feasibility Assessment
(Reference product verification, CDSCO compliance, biowaiver feasibility)Protocol Development & Ethics Approval
(IEC submission through registered ethics committees)Analytical Method Development
(LC-MS/MS/HPLC validation as per ICH M10)Clinical Study Execution
(Volunteer recruitment, dosing, PK sampling under GCP)Bioanalysis & PK Evaluation
(PK modeling, QC check & BE statistics)Final Reports & Submission Package
(CSR, CDP report, validation files & CTD-ready documentation)
Who We Support in Baddi
• Large-scale formulation manufacturers
• Contract manufacturing organizations (CMOs)
• R&D and formulation development teams
• Start-ups preparing to enter regulated markets
• Export-focused pharmaceutical companies