🇲🇦 Bioavailability & Bioequivalence (BA/BE) Studies Services for Morocco

DMP-Morocco / ICH-Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt. Ltd., provides comprehensive Bioavailability & Bioequivalence (BA/BE) Study Services and Comparative Dissolution Profiling (CDP) aligned with the regulatory requirements of Morocco’s Ministry of Health & Social Protection, specifically the Direction du Médicament et de la Pharmacie (DMP).

Our services comply with Moroccan pharmaceutical regulations, WHO TRS, ICH, GCP, and GLP, supporting pharmaceutical companies seeking generic product registration in Morocco and North Africa.

💊 Core Services for Morocco (DMP) Regulatory Submissions

1. Clinical BA/BE Studies (Human)

• Study Designs: Single-dose & multiple-dose; crossover and parallel studies per DMP requirements.

• Volunteer Recruitment: Healthy volunteer studies conducted according to global ICH-GCP standards.

• Ethics Approval: Approval from accredited Comité d’Éthique de la Recherche Biomédicale (CERB).

• Protocol Development: Compliant with ICH E6 (R2), WHO BA/BE guidance, and Moroccan regulatory expectations.

2. Comparative Dissolution Profiling (CDP)

• Regulatory Role: Required for generic registration, formulation comparisons, and post-approval variations.

• Dissolution Media: Biorelevant & pharmacopoeial solutions compliant with USP/Ph.Eur. norms.

• Profile Comparison: f2 similarity factor, additional model-based dissolution comparisons.

• Report Format: Prepared according to Morocco CTD Module 3 requirements.

3. IVIVC & Biowaiver Support

• BCS-Based Biowaiver: Prepared according to ICH Q6A, WHO BCS, and Moroccan dossier expectations.

• IVIVC Modeling: Level A, B & C correlation tools.

• Predictive Evaluation: Linking dissolution and PK behavior to support waiver justification.

4. Analytical Method Development & Validation

• Platforms: LC-MS/MS & HPLC-UV analytical technologies.

• Validation: Conducted according to ICH M10 and Moroccan analytical standards.

• Stability Studies: Stability-indicating methods suitable for CTD submission to DMP.

5. Pharmacokinetic (PK) & Bioequivalence Statistics

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

• BE Evaluation: CI-based assessment of AUC, Cmax, and key PK metrics using ICH/WHO norms.

• Sample Size: Determined through power calculations consistent with BE variability requirements.

📑 Morocco (DMP)–Ready Regulatory Documentation

We prepare full Morocco CTD-compatible dossiers ready for submission to the DMP:

• Clinical Study Protocol

• Informed Consent Forms (Arabic/French/English as required)

• Investigator’s Brochure

• Clinical Study Report (CSR) compliant with DMP expectations

• Bioanalytical Method Validation Report

• Comparative Dissolution Profiling Report

• CTD/ACTD Modules (1–5) for Morocco

• Moroccan regulatory templates for generic medicine registration

✨ Why Choose BioEquiGlobal for the Moroccan Market?

• Regulatory Alignment: Expertise in DMP-Morocco procedures and North African pharmaceutical regulations.

• Quality Assurance: GCP, GLP, WHO, and ICH-aligned systems ensuring regulatory acceptance.

• Accredited Infrastructure: Advanced analytical labs and certified clinical research units.

• Regional & International Reach: Support for Morocco + North Africa (Tunisia, Algeria, Egypt), ECOWAS, GCC, EU, US FDA, and global submissions.

🗺️ Our BA/BE Workflow for Morocco

1. Feasibility & Regulatory Assessment

Review of reference product, BCS class, and alignment with Moroccan dossier requirements.

2. Protocol Development & Ethics Approval

Creation of a WHO/ICH-compliant protocol and securing CERB ethics approval.

3. Analytical Method Development & Validation

LC-MS/MS method development and ICH M10-compliant validation.

4. Clinical Study Execution

GCP-governed volunteer recruitment, dosing, sample handling, and medical oversight.

5. Bioanalysis, PK & BE Evaluation

Bioanalytical testing, PK computation, BE statistical assessment.

6. Documentation & DMP CTD Submission

CTD Module preparation (1–5), CSR, CDP, and supplementary Moroccan application forms.

Who We Support in Morocco & North Africa

• Generic medicine manufacturers registering products with DMP-Morocco.

• Regional companies seeking expanded Maghreb regulatory coverage (Morocco, Algeria, Tunisia).

• CROs outsourcing clinical or analytical BA/BE components.

• Regulatory teams preparing CTD/ACTD dossiers for Morocco.