🇰🇲 Bioavailability & Bioequivalence (BA/BE) Studies Services for Comoros

ANAM-Comores / WHO-Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt. Ltd., provides comprehensive Bioavailability/Bioequivalence (BA/BE) study services and Comparative Dissolution Profiling (CDP) tailored to the regulatory framework of the Union of Comoros, overseen by ANAM (Agence Nationale des Médicaments).

Our studies comply with WHO TRS, ICH, GCP, GLP, and emerging African Medicines Agency (AMA) harmonization initiatives — supporting pharmaceutical companies seeking drug approvals in Comoros and across the Indian Ocean region.

💊 Core Services for Comoros (ANAM) Regulatory Submissions

Clinical BA/BE Studies (Human)

• Study Designs: Single-dose & multiple-dose; crossover & parallel designs aligned with WHO/ICH guidance.

• Volunteer Selection: Healthy volunteers selected under internationally accepted GCP standards.

• Ethics Approval: Mandatory approval from a recognized Ethics Committee (Comoros or partnered regional EC).

• Protocol Standards: Prepared according to ICH E6 (R2), WHO BA/BE guidance, and ANAM submission norms.

Comparative Dissolution Profiling (CDP)

• Regulatory Requirement: Essential for generic medicine registration or formulation changes under ANAM & WHO guidelines.

• Dissolution Media: Biorelevant & standard pharmacopoeial media.

• Similarity Evaluation: f2 similarity factor calculation and model-based kinetic analysis.

• Reporting: Fully structured CDP report aligned with WHO Prequalification and ANAM expectations.

IVIVC & Biowaiver Support

• BCS Biowaiver: Prepared following WHO, ICH Q6A, and African regulatory harmonization principles.

• IVIVC Modeling: Level A, B, and C IVIVC methods for biopharmaceutic evaluation.

• Predictive Modeling: Assessment of in vitro–in vivo correlation to support regulatory waivers.

Analytical Method Development & Validation

• Platforms Used: LC-MS/MS and HPLC-UV for drug quantification.

• Validation Standards: As per ICH M10 and WHO-recommended validation structures.

• Stability Studies: Stability-indicating method development for APIs & finished dose forms.

Pharmacokinetic (PK) & Bioequivalence Statistics

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

• BE Statistics: Confidence-interval–based evaluation, ANOVA, and internationally recognized BE metrics.

• Sample Size Calculation: Power-based estimates aligned with WHO/ICH standards.

📑 Comoros (ANAM)–Ready Regulatory Documentation

We prepare complete, submission-ready documentation suitable for ANAM Comoros, African Medicines Agency (AMA) alignment, and WHO PQ expectations.

Documentation includes:

• Clinical Study Protocol

• Informed Consent Forms (French/English if required)

• Investigator’s Brochure

• Clinical Study Report (CSR) in WHO/ICH-compliant format

• Bioanalytical Method Validation Report

• Comparative Dissolution Profile Report

• CTD/ACTD Modules structured for Comoros

• Supplemental ANAM-required submission forms

✨ Why Choose BioEquiGlobal for Comoros?

• Regulatory Familiarity: Understanding of ANAM-Comores processes and WHO-aligned regulatory systems.

• Global Standardization: GCP, GLP, and ICH-driven processes ensuring international acceptance.

• Modern Infrastructure: Access to validated laboratories and accredited clinical research environments.

• Regional & International Reach: Submission-ready dossiers for Comoros, Madagascar, Mauritius, Seychelles, East Africa, GCC, EU, US FDA, and more.

🗺️ Our BA/BE Workflow for Comoros

1. Feasibility & Regulatory Assessment

Evaluation of reference product, BCS classification, and ANAM-related dossier requirements.

2. Protocol Development & Ethics Approval

Creation of WHO/ICH-aligned study protocols and securing ethical approval.

3. Analytical Method Development

LC-MS/MS method development and validation following ICH M10 standards.

4. Clinical Study Execution

GCP-governed volunteer recruitment, dosing, sampling, and safety monitoring.

5. Bioanalysis, PK & BE Evaluation

Full bioanalytical testing, PK computation, and BE statistical analysis.

6. Documentation & CTD Submission

Preparation of CSR, CDP report, and CTD modules for ANAM submission.

Who We Support in Comoros & the Indian Ocean Region

• Pharmaceutical manufacturers registering generics in Comoros.

• Companies targeting multi-country submissions in the Indian Ocean region.

• CROs outsourcing BA/BE analytical or clinical activities.

• Regulatory teams preparing CTD/ACTD dossiers.