🇸🇨 Bioavailability & Bioequivalence (BA/BE) Studies Services for Seychelles

NPRA–Seychelles / WHO-Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt. Ltd., provides full Bioavailability/Bioequivalence (BA/BE) study services and Comparative Dissolution Profiling (CDP) tailored for the regulatory framework of Seychelles’ National Pharmaceutical Regulatory Authority (NPRA) under the Ministry of Health.

Our studies follow WHO Technical Report Series, ICH, GCP, and GLP standards — ensuring globally accepted data for pharmaceutical companies registering generic medicines in Seychelles and the Indian Ocean region.

💊 Core Services for Seychelles (NPRA) Regulatory Submissions

1. Clinical BA/BE Studies (Human)

• Study Types: Single-dose and multiple-dose BE studies; crossover & parallel designs.

• Volunteer Selection: Healthy volunteer recruitment compliant with international GCP standards.

• Ethics Approval: Approval from a recognized Ethics Committee (local or regional IRB accepted, per Seychelles guidelines).

• Protocol Development: Aligned with ICH E6 (R2) and WHO BA/BE recommendations, compatible with NPRA requirements.

2. Comparative Dissolution Profiling (CDP)

• Requirement: Mandatory for generic drug applications and formulation variations.

• Media: Biorelevant & pharmacopoeial dissolution media (USP/Ph.Eur./WHO).

• Similarity Evaluation: f2 similarity factor, kinetic & statistical comparison.

• Output: Complete CDP documentation suitable for CTD Module 3 submission to NPRA.

3. IVIVC & Biowaiver Support

• BCS Biowaiver: Prepared as per WHO, ICH Q6A, and global biopharmaceutics guidance.

• IVIVC Models: Level A, B, and C correlation.

• Predictive Performance: PK–dissolution modeling for regulatory justification.

4. Analytical Method Development & Validation

• Platforms: LC-MS/MS and HPLC-UV.

• Validation: Conducted as per ICH M10 for bioanalytical method validation.

• Stability Methods: For both APIs and finished pharmaceutical products.

5. Pharmacokinetic (PK) & Bioequivalence Statistics

• PK Approach: Non-compartmental analysis (NCA).

• BE Statistical Evaluation: CI-based assessment of AUC, Cmax per WHO/ICH acceptance criteria.

• Sample Size & Power: Calculated based on PK variability to satisfy BE requirements.

📑 Seychelles NPRA–Ready Regulatory Documentation

We prepare complete CTD documentation tailored to Seychelles NPRA expectations:

• Clinical Study Protocol

• Informed Consent Forms (English)

• Investigator’s Brochure

• Clinical Study Report (CSR) – WHO/ICH-compliant

• Bioanalytical Method Validation Report

• Comparative Dissolution Profile Report

• CTD Modules 1–5 prepared for NPRA

• Additional NPRA regulatory templates (when required)

✨ Why Choose BioEquiGlobal for Seychelles?

• Regulatory Alignment: Understanding of NPRA requirements and WHO-compliant dossier structures.

• Quality Standards: GCP, GLP, WHO, and ICH-driven execution ensures global acceptability.

• Modern Facilities: Access to validated analytical labs and clinical units meeting international standards.

• Regional Coverage: Support for Seychelles, Mauritius, Madagascar, Comoros, and broader African markets.

• Global Submission Capability: Dossier readiness for US FDA, EMA, MHRA, GCC, India, and other global agencies.

🗺️ Our BA/BE Workflow for Seychelles

1. Feasibility & Regulatory Assessment

Review of reference product, BCS classification, and NPRA submission requirements.

2. Protocol Development & Ethics Approval

Creation of ICH/WHO-compliant protocols and securing ethics approval from a recognized committee.

3. Analytical Method Development

LC-MS/MS method development, validation (ICH M10), and stability evaluation.

4. Clinical Study Execution

Volunteer enrolment, dosing, blood sampling, and oversight in accordance with GCP.

5. Bioanalysis, PK & BE Evaluation

Bioanalytical testing, PK modeling, and BE statistics.

6. Documentation & Submission Preparation

CSR finalization, CDP reports, and CTD assembly ready for NPRA submission.

Who We Support in Seychelles & the Indian Ocean Region

• Pharmaceutical manufacturers registering generics with NPRA.

• Companies expanding to Indian Ocean markets (Seychelles, Mauritius, Madagascar, Comoros).

• CROs outsourcing BA/BE clinical or analytical components.

• Regulatory teams preparing CTD/ACTD dossiers.