🇮🇳 Bioavailability & Bioequivalence (BA/BE) Studies Services for Surat
CDSCO-Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides complete Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling for pharmaceutical companies, CROs, and R&D units operating in Surat, one of Gujarat’s fastest-growing industrial and pharmaceutical clusters.
All studies comply with:
CDSCO (Central Drugs Standard Control Organization)
New Drugs & Clinical Trials Rules (NDCTR), 2019
ICH GCP & WHO TRS
GLP analytical standards
ICMR Ethical Guidelines
We support CDSCO/DCGI submissions, as well as global regulatory submissions to USFDA, EMA, MHRA, TGA, Health Canada, and other agencies.
💊 Core BA/BE Services for Surat’s Pharma, Chemical & CRO Sector
Clinical BA/BE Studies (Human)
• Crossover & parallel designs (single-dose & multiple-dose).
• Healthy volunteer and patient-based studies, depending on therapeutic category.
• IEC approval through CDSCO-registered Ethics Committees in Gujarat.
• Protocol development aligned with ICH E6 (R2), WHO TRS & CDSCO regulatory expectations.
Comparative Dissolution Profiling (CDP)
• Required for generic drug development, Form 44 submissions, and FDC approvals.
• Dissolution studies performed in IP/USP/EP & biorelevant media.
• f2 similarity factor for dissolution comparison.
• Model-independent and model-dependent dissolution analysis.
IVIVC & Biowaiver Support
• BCS-based biowaiver preparation following CDSCO, WHO TRS, and ICH Q6A guidelines.
• Level A/B/C IVIVC modeling for predictive dissolution–PK correlation.
• Supports waiver of in vivo BE studies where justified.
Analytical Method Development & Validation
• LC-MS/MS & HPLC-UV analytical method development.
• Validation per ICH M10 and CDSCO bioanalytical requirements.
• Stability-indicating methods for APIs and finished dosage forms.
Pharmacokinetic (PK) & BE Statistical Analysis
• Non-compartmental PK analysis (NCA).
• BE assessments using standard 90% CI acceptance ranges.
• Power & sample-size calculations for optimized study design.
📑 CDSCO-Compliant Documentation for Surat Submissions
We prepare complete regulatory documentation, including:
• Clinical Study Protocol
• Informed Consent Form (ICF)
• Investigator Brochure
• Clinical Study Report (CSR) as per CDSCO & ICH E3
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules (1–5) for Form 44 & international submissions
✨ Why Choose BioEquiGlobal for Surat?
• Growing Pharma & Chemical Manufacturing Hub: Surat’s expanding industrial ecosystem supports formulation development and export markets.
• Regulatory Expertise: Thorough understanding of NDCTR, CDSCO expectations & global regulatory filing pathways.
• Strong Infrastructure Access: Connects easily to NABL-certified analytical labs and accredited clinical trial facilities.
• Ideal for Export-Oriented Manufacturers: Expertise in ANDA/CTD documentation for regulated markets.
• End-to-End Support: From dissolution profiling to full BA/BE study execution and CTD dossier submission.
🗺️ BA/BE Study Workflow for Surat Sponsors
Feasibility & Regulatory Assessment
(Reference product evaluation, CDSCO mapping, biowaiver feasibility check)Protocol Development & IEC Approval
(Ethics submission to IECs in Gujarat/NCR)Analytical Method Development & Validation
(LC-MS/MS validation per ICH M10)Clinical BA/BE Study Execution
(Volunteer recruitment, dosing, PK sampling & GCP-compliant monitoring)Bioanalysis & PK/BE Evaluation
(PK modeling, QC checks, BE statistical analysis)Final Documentation & Submission
(CSR, CDP report, analytical validation & CTD-ready files)
Who We Support in Surat
• Formulation & API manufacturers
• CROs & bioanalytical laboratories
• Pharmaceutical R&D and QC/QA units
• Export-driven pharma companies
• Start-ups entering regulated markets