🇮🇳 Bioavailability & Bioequivalence (BA/BE) Studies Services for Panaji–Goa

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 to support pharmaceutical companies located across Goa, including Panaji, Verna Industrial Estate, Ponda, Kundaim, Colvale, and Tuem.

Goa is a major pharmaceutical manufacturing hub, especially for export-focused formulations — making regulatory-compliant BA/BE services essential for product approvals.

All studies are conducted following:

• CDSCO (Central Drugs Standard Control Organization)

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

• ICH GCP & WHO TRS

• GLP-certified analytical processes

• ICMR Ethical Guidelines

We support regulatory submissions for CDSCO, as well as global agencies: USFDA, EMA, MHRA, TGA, Health Canada, GCC, SAHPRA, and more.

💊 Core BA/BE Services for Goa’s Pharma Manufacturing Cluster

Clinical BA/BE Studies (Human)

• Single-dose & multiple-dose BE studies (crossover/parallel).
• Healthy volunteer or patient-based studies depending on therapeutic class.
• IEC approval via CDSCO-registered Ethics Committees in Goa/nearby NCR hubs.
• Protocol design aligned with ICH E6 (R2), WHO TRS & CDSCO guidelines.

Comparative Dissolution Profiling (CDP)

• Required for Form 44 submissions, FDC approvals, and post-approval stability/formulation changes.
• Dissolution studies in IP/USP/EP & biorelevant media (FaSSIF/FeSSIF).
• f2 similarity factor evaluation for dissolution comparison.
• Model-dependent and model-independent dissolution assessments.

IVIVC & Biowaiver Support

• BCS-based biowaiver preparations per CDSCO, WHO TRS, and ICH Q6A guidelines.
• Level A/B/C IVIVC modeling for predictive PK correlations.
• Supports waiver of in vivo studies in applicable cases.

Analytical Method Development & Validation

• State-of-the-art LC-MS/MS & HPLC-UV platforms.
• Method validation following ICH M10 & CDSCO requirements.
• Stability-indicating methods for APIs and finished dosage forms.

Pharmacokinetic (PK) & BE Statistical Evaluation

• Non-compartmental PK analysis (NCA).
• BE evaluation using the standard 90% CI acceptance range.
• Sample-size & power calculations based on intra-subject variability.

📑 CDSCO-Compliant Documentation for Goa 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 (CDP) Report
• CTD/ACTD Modules (1–5) for Form 44 & international filings

✨ Why Choose BioEquiGlobal for Goa?

• Strong Presence in Goa’s Pharma Belt: Goa hosts many leading export-oriented pharmaceutical manufacturers, making BA/BE support crucial.
• Regulatory Accuracy: Expertise with NDCTR, CDSCO guidelines, and international regulatory expectations.
• Infrastructure Access: Connection with NABL-certified analytical labs and accredited clinical research facilities.
• Ideal for Export Markets: Specialized support for ANDA, CTD, eCTD submissions for highly regulated global markets.
• End-to-End Partner: From dissolution development and clinical BE to final dossier submission.

🗺️ BA/BE Study Workflow for Goa-Based Sponsors

1. Feasibility & CDSCO Regulatory Assessment
   (Reference product selection, biowaiver evaluation, dossier planning)

2. Protocol Development & IEC Approval
   (Ethics submission through recognized committees)

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

4. Clinical BA/BE Study Execution
   (GCP-compliant dosing, sampling, and safety monitoring)

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

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

Who We Support in Goa

• Large-scale formulation manufacturers
• Export-oriented pharma companies (NDA/ANDA/CTD markets)
• CROs & bioanalytical laboratories
• R&D-focused pharma units
• Biotech & specialty pharma companies
• Start-ups entering global regulated markets