🇸🇷 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
Feasibility & Gap Assessment: Review of reference product availability, dissolution comparability, and biowaiver potential.
Protocol Development: Drafting Suriname-compliant BA/BE protocols and coordinating ethical approvals.
Analytical Method Development: LC-MS/MS method validation per ICH M10 & WHO TRS.
Clinical Study Execution: GCP-supervised volunteer recruitment, dosing, PK sampling, and safety monitoring.
Bioanalysis & PK Evaluation: PK modeling, QC checks, and BE statistical analysis.
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