🇲🇽 Bioavailability & Bioequivalence (BA/BE) Studies Services for Mexico

COFEPRIS–Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal

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

• COFEPRIS – Comisión Federal para la Protección contra Riesgos Sanitarios

• Secretaría de Salud (Ministry of Health)

All studies strictly follow COFEPRIS regulations, NOM (Normas Oficiales Mexicanas) standards, ICH guidelines, WHO TRS, GCP, and GLP, ensuring compliance for national registrations and international regulatory acceptance.

💊 Core Services for Mexico (COFEPRIS) Regulatory Submissions

Clinical BA/BE Studies (Human)

• Regulatory Basis: Mexican Official Standards including NOM-177-SSA1, which governs BE studies.
• Study Designs: Single-dose & multiple-dose BE studies in crossover or parallel designs following NOM-177 criteria.
• Volunteer Selection: Healthy volunteers or indication-specific patient groups as required.
• Ethics Approval: Mandatory approval from a CEI – Comité de Ética en Investigación, accredited in Mexico.
• Protocol Development: Developed per NOM-177, ICH E6 (R2) GCP, WHO TRS, and COFEPRIS review expectations.

Comparative Dissolution Profiling (CDP)

• Regulatory Requirement: Mandatory for pharmaceutical equivalence and generic submissions under NOM standards.
• Dissolution Media: As specified in NOM-177, pharmacopeial and biorelevant media recognized by COFEPRIS.
• Similarity Factor: f2 similarity factor for comparing dissolution profiles.
• Evaluation Approaches: Model-independent (f1, f2) and model-dependent comparisons aligned with WHO/ICH guidelines.

IVIVC & Biowaiver Support

• BCS-Based Biowaiver: Prepared in accordance with NOM-177, WHO TRS, and ICH Q6A.
• IVIVC Models: Level A, B, and C modeling.
• Predictive PK Modeling: Supports biowaiver justification and BE strategy optimization.

Analytical Method Development & Validation

• Technologies: LC-MS/MS and HPLC-UV platforms.
• Validation: Conducted under NOM-177, ICH M10, and WHO TRS guidelines.
• Stability-Indicated Methods: Developed for APIs and finished dosage forms following COFEPRIS requirements.

Pharmacokinetic (PK) Analysis

• Approach: Non-compartmental analysis (NCA).
• Statistical BE Evaluation: Performed according to NOM-177-SSA1 and WHO/ICH harmonized standards.
• Sample Size & Power: Scientifically justified to meet COFEPRIS statistical criteria.

📑 Mexico COFEPRIS–Ready Regulatory Documentation

We prepare complete regulatory documentation tailored for COFEPRIS submission, including:

• Clinical Study Protocol aligned with NOM-177 and COFEPRIS
• Informed Consent Forms (ICF) meeting Mexican ethical standards
• Investigator Brochure
• Clinical Study Report (CSR) compliant with ICH & WHO TRS
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules (1–5) formatted for COFEPRIS drug registration

✨ Why Choose BioEquiGlobal for the Mexican Market?

• NOM-177 Expertise: All BE designs, dissolution studies, and validation processes aligned with Mexican Official Standards.
• Strict Quality Compliance: GCP, GLP, ICH, and WHO TRS standards upheld through rigorous QA systems.
• Robust Clinical & Analytical Infrastructure: Accredited clinical units and advanced analytical laboratories (including NABL-certified labs).
• Global Submission Readiness: CTD dossiers prepared for Mexico and international agencies (US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.).

🗺️ BA/BE Study Workflow for Mexico

1. Feasibility & Gap Assessment: Evaluation of reference product, dissolution comparability, and biowaiver feasibility according to NOM-177.

2. Protocol Development: Drafting COFEPRIS- and NOM-compliant protocols; coordinating CEI ethics approval.

3. Analytical Method Development: LC-MS/MS validation following NOM-177, ICH M10, and WHO TRS.

4. Clinical Execution: Strict GCP-supervised recruitment, dosing, sampling, and safety monitoring.

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

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

Who We Support

• Pharmaceutical companies targeting the Mexican market
• CROs requiring BE/analytical outsourcing
• Regulatory teams needing COFEPRIS-compliant CTD/ACTD dossiers