🇹🇹 Bioavailability & Bioequivalence (BA/BE) Studies Services for Trinidad & Tobago

The CFDD operates under the Food and Drugs Act and Regulations and requires comprehensive documentation, including evidence of Bioequivalence (BE) studies, for the registration of generic drugs.

💊 Core Requirements for New Drug Submissions

• Mandatory Data: All New Drug Submissions (NDS) must include all relevant technical data, including clinical data and Bioequivalence Studies (Source 2.2).

• Dossier Structure: The submission is presented in four separate sections (dossiers), or modules, which are similar to the international Common Technical Document (CTD) format:

  1. Administrative

  2. Chemical Documentation

  3. Clinical (must include non-clinical data and clinical data, including Bioequivalence Studies)

  4. Other (e.g., Packaging Information)

• Certificate of Product: The application must include an original, apostilled, and attested Certificate of Pharmaceutical Product (CPP), issued by the National Regulatory Authority (NRA) of the manufacturing country, confirming compliance with Good Manufacturing Practices (GMP) (Source 2.2).

🔬 Bioequivalence (BE) Study Requirements

The CFDD relies on international standards—specificCFDD–Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, delivers complete Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling aligned with Trinidad & Tobago’s regulatory requirements under:

• Chemistry, Food & Drugs Division (CFDD)

• Ministry of Health, Trinidad and Tobago

All studies strictly follow CFDD pharmaceutical requirements, ICH guidelines, WHO TRS, GCP, and GLP, ensuring readiness for national submissions and regional Caribbean approvals.

💊 Core Services for Trinidad & Tobago (CFDD) Regulatory Submissions

Clinical BA/BE Studies (Human)

• Study Designs: Single-dose & multiple-dose BE studies in crossover or parallel formats.
• Volunteer Selection: Healthy volunteers or patient-specific groups depending on product classification.
• Ethics Approval: Required approval from a local Institutional Review Board (IRB)/Ethics Committee recognized by the Ministry of Health.
• Protocol Development: Designed according to ICH E6 (R2) GCP, WHO TRS, and CFDD expectations.

Comparative Dissolution Profiling (CDP)

• Regulatory Requirement: Required for generic registration, formulation modifications, and equivalence evaluation.
• Dissolution Media: Pharmacopeial and biorelevant media accepted by CFDD.
• Similarity Factor: f2 similarity factor for dissolution profile comparison.
• Evaluation Approaches: WHO/ICH-compliant model-independent (f1, f2) and model-dependent dissolution models.

IVIVC & Biowaiver Support

• BCS-Based Biowaiver: Prepared per WHO TRS and ICH Q6A, acceptable within CFDD submission formats.
• IVIVC Modeling: Level A, B, and C in vitro–in vivo correlation models.
• Predictive PK Modeling: Supports regulatory justification for biowaiver requests.

Analytical Method Development & Validation

• Platforms: LC-MS/MS and HPLC-UV analytical systems.
• Validation: According to ICH M10, WHO TRS, and CFDD-compatible validation requirements.
• Stability-Indicating Methods: Developed for APIs and finished pharmaceutical dosage forms.

Pharmacokinetic (PK) Analysis

• PK Methodology: Non-compartmental analysis (NCA).
• BE Statistical Analysis: Conducted using WHO/ICH harmonized standards.
• Sample Size & Power: Calculated scientifically to ensure reliable BE outcomes.

📑 Trinidad & Tobago CFDD–Ready Regulatory Documentation

We prepare complete, CFDD-specific regulatory documentation packages, including:

• Clinical Study Protocol (Trinidad & Tobago–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) formatted for submission to CFDD

✨ Why Choose BioEquiGlobal for the Trinidad & Tobago Market?

• Regulatory Expertise: BE protocols, PK analysis, dissolution studies, and CTDs tailored to CFDD requirements.
• High International Standards: GCP, GLP, WHO TRS, and ICH compliance supported by strong QA systems.
• Advanced Research Infrastructure: Accredited clinical units and high-quality analytical laboratories (including NABL-certified labs).
• Global Submission Capability: CTD dossiers prepared for Trinidad & Tobago and international regulators (US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.).

🗺️ BA/BE Study Workflow for Trinidad & Tobago

1. Feasibility & Gap Assessment: Assessment of reference product availability, dissolution comparison, and biowaiver feasibility.

2. Protocol Development: Drafting CFDD-compliant BE protocols and coordinating IRB/ethics approval.

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

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

5. Bioanalysis & PK Evaluation: PK modeling, QC verification, and BE statistical interpretation.

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

Who We Support

• Pharmaceutical manufacturers targeting Trinidad & Tobago and the Caribbean region
• CROs requiring BA/BE or analytical outsourcing
• Regulatory teams needing CFDD-compliant CTD/ACTD dossiersally WHO (World Health Organization) Technical Report Series (TRS) and ICH (International Council for Harmonisation) guidelines—to ensure multisource (generic) products are therapeutically equivalent to the innovator product.

• Study Design: The expected design is the standard randomized, single-dose, two-period, two-sequence, crossover study in healthy adult subjects, conducted under Good Clinical Practice (GCP) standards.

• Acceptance Criteria: Statistical analysis of the pharmacokinetic (PK) parameters, the Area Under the Curve ($\text{AUC}$) and the Maximum Concentration ($\text{C}_{\text{max}}$), must show the $90\%$ Confidence Interval (CI) for the geometric mean ratio of the test to reference product falls within the standard international range of $80.00\%$ to $125.00\%$ (Source 3.5).

• Biowaivers: The CFDD is likely to accept BCS-based Biowaiver applications (for specific low-risk, immediate-release dosage forms) that comply with WHO guidelines (Source 3.1).

📑 Other Key Requirements

• Language: Documentation must be submitted in the English Language (the official language of Trinidad and Tobago).

• Samples: Three (3) samples of the finished drug and samples of the active ingredient(s) must be provided for laboratory assessment (Source 2.2).