🇸🇷 Bioavailability & Bioequivalence (BA/BE) Studies Services for Suriname

BOG / Pharmaceutical Inspectorate–Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, offers comprehensive Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling aligned with Suriname’s pharmaceutical regulatory requirements under:

• BOG – Bureau for Public Health (Bureau Openbare Gezondheidszorg)

• Pharmaceutical Inspectorate (Pharmaceutische Inspectie)

• Ministry of Health, Suriname

All studies comply with Suriname’s registration guidelines, WHO TRS, ICH standards, GCP, and GLP, ensuring readiness for national submissions and broader CARICOM approvals.

💊 Core Services for Suriname (BOG / Pharmaceutical Inspectorate) Regulatory Submissions

Clinical BA/BE Studies (Human)

• Study Designs: Single-dose & multiple-dose crossover or parallel BE designs accepted within Suriname and CARICOM frameworks.
• Volunteer Selection: Healthy volunteers or patient-specific groups depending on therapeutic indication.
• Ethics Approval: Required approval from a Suriname-based Medical Ethical Review Committee under the Ministry of Health.
• Protocol Development: Prepared per ICH E6 (R2) GCP, WHO TRS, and BOG/Pharmaceutical Inspectorate requirements.

Comparative Dissolution Profiling (CDP)

• Regulatory Requirement: Essential for generic product registration, post-approval variations, and equivalence assessment.
• Dissolution Media: Pharmacopeial & biorelevant media compatible with Suriname’s regulatory expectations.
• Similarity Factor: f2 similarity factor for dissolution profile comparison.
• Evaluation Models: WHO/ICH-approved model-independent (f1, f2) and model-dependent approaches.

IVIVC & Biowaiver Support

• BCS-Based Biowaiver: Prepared according to WHO TRS and ICH Q6A; accepted within Suriname’s regulatory ecosystem.
• IVIVC Models: Level A, B, and C modeling for robust in vitro–in vivo correlation.
• Predictive PK Modeling: Supports biowaiver justification and regulatory decision-making.

Analytical Method Development & Validation

• Platforms: LC-MS/MS and HPLC-UV analytical systems.
• Validation: Per ICH M10, WHO TRS, and validation practices recognized within CARICOM.
• Stability-Indicating Methods: Developed for APIs and finished pharmaceutical products.

Pharmacokinetic (PK) Analysis

• PK Approach: Non-compartmental analysis (NCA).
• BE Statistics: Carried out using WHO/ICH harmonized BE criteria.
• Sample Size & Power: Scientifically determined to ensure reliable BE conclusions.

📑 Suriname BOG–Ready Regulatory Documentation

We prepare complete documentation tailored to Suriname’s regulatory infrastructure, including:

• Clinical Study Protocol (Suriname-compliant)
• Informed Consent Forms (ICF) meeting national ethics requirements
• Investigator Brochure
• Clinical Study Report (CSR) per ICH & WHO TRS structure
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules (1–5) suitable for BOG/Pharmaceutical Inspectorate submission

✨ Why Choose BioEquiGlobal for the Surinamese Market?

• Regulatory Familiarity: Understanding of Suriname’s BOG and Pharmaceutical Inspectorate requirements.
• Compliance with International Standards: GCP, GLP, WHO TRS, and ICH adherence with strong QA oversight.
• Modern Infrastructure: Advanced analytical laboratories (including NABL-certified), and accredited clinical research units.
• Regional & International Submission Support: CTD dossiers suitable for Suriname, CARICOM, and major global regulators (US FDA, EMA, MHRA, TGA, SAHPRA, GCC, etc.).

🗺️ BA/BE Study Workflow for Suriname

1. Feasibility & Gap Assessment: Review of reference product availability, dissolution comparability, and biowaiver potential.

2. Protocol Development: Drafting Suriname-compliant BA/BE protocols and coordinating ethical approvals.

3. Analytical Method Development: LC-MS/MS method validation per ICH M10 & WHO TRS.

4. Clinical Study Execution: GCP-supervised volunteer recruitment, dosing, PK sampling, and safety monitoring.

5. Bioanalysis & PK Evaluation: PK modeling, QC checks, and BE statistical analysis.

6. Documentation & Submission: Preparation of BOG-ready CSR, CDP report, validation documents, and CTD/ACTD modules.

Who We Support

• Pharmaceutical companies targeting Suriname and the CARICOM region
• CROs requiring BA/BE outsourcing or analytical support
• Regulatory teams needing BOG/Pharmaceutical Inspectorate–compliant CTD/ACTD dossiers