🇶🇦 Bioavailability & Bioequivalence (BA/BE) Studies Services for Qatar

MOPH-Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal

BioEquiGlobal, a dedicated scientific brand of Zoesoe Exports Pvt. Ltd., provides complete Bioavailability/Bioequivalence (BA/BE) study services and Comparative Dissolution Profiling (CDP) tailored to the regulatory framework of Qatar’s Ministry of Public Health (MOPH) and the Pharmacy & Drug Control Department (PDCD).

Our studies adhere to GCC Drug Regulatory Standards, ICH, WHO TRS, GCP, and GLP requirements, supporting pharmaceutical companies seeking registration in Qatar and wider GCC markets.

💊 Our Core Services for Qatar Regulatory Submissions

Clinical BA/BE Studies (Human)

• Study Design: Single-dose & multiple-dose, crossover & parallel designs aligned with GCC regulatory guidance.

• Volunteer Selection: Healthy volunteer/patient studies as accepted by Qatar’s PDCD and international GCP standards.

• Ethics Approval: Review and approval from an accredited Institutional Review Board (IRB)/Ethics Committee under Qatar’s regulations for clinical research.

• Protocol Compliance: Protocols aligned with MOPH/PDCD requirements, ICH E6 (R2), and GCC guidelines.

Comparative Dissolution Profiling (CDP)

• Regulatory Requirement: Essential for generic product evaluation and variations under GCC and Qatar PDCD guidelines.

• Media: Standard & biorelevant media following GCC dissolution method expectations.

• Data Analysis: Similarity factor (f2) and model-dependent comparisons as required for PDCD submissions.

• Output: Comprehensive statistical and graphical dissolution comparison reports.

IVIVC & Biowaiver Support

• BCS-Based Biowaiver: Developed according to GCC guidelines, ICH Q6A, and internationally harmonized MOPH expectations.

• IVIVC Modeling: Level A, B, and C correlation models.

• Predictive Assessment: In vitro–in vivo predictive dissolution and PK evaluation.

Analytical Method Development & Validation

• Instrumentation: LC-MS/MS and HPLC-UV analysis for drug quantification.

• Validation Standards: As per ICH M10 and GCC-recommended bioanalytical method validation principles.

• Stability Studies: Stability-indicating method development for APIs and finished pharmaceutical products.

Pharmacokinetic (PK) & Statistical Analysis

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

• Bioequivalence Statistics: ANOVA, confidence interval evaluation, and other BE statistical methods accepted by GCC regulators.

• Sample Size & Power: Determined according to BE variance estimates and GCC guidelines.

📑 Qatar (MOPH/PDCD)–Ready Regulatory Documentation

We prepare complete documentation packages compatible with Qatar’s Ministry of Public Health and GCC Drug Registration Format (GCC-DR).

Documents include:

• Clinical Study Protocol

• Informed Consent Forms (Arabic/English as required)

• Investigator’s Brochure

• Clinical Study Report (CSR) tailored for GCC/MOPH submission structure

• Bioanalytical Method Validation Report

• Comparative Dissolution Profile Report

• CTD/ACTD Modules adapted for Qatar’s regulatory submission (MOPH/PDCD)

• Additional GCC forms required for generic drug registration

✨ Why Choose BioEquiGlobal for Qatar?

• Aligned with Qatar Regulatory System: Expertise in MOPH/PDCD expectations and GCC unified drug registration framework.

• Quality Assurance: Internal QA audits, GCP-compliant clinical operations, and GLP-driven laboratories.

• State-of-the-Art Infrastructure: Accredited clinical units and analytical laboratories with international certifications (e.g., NABL or equivalent).

• Support for Global Markets: Beyond Qatar/GCC, dossiers can be simultaneously prepared for US FDA, EMA, MHRA, TGA, and other international agencies.

🗺️ Our BA/BE Workflow for Qatar

1. Feasibility & Regulatory Gap Assessment

Evaluation of reference product, GCC registration status, and requirements for Qatar PDCD submission.

2. Protocol Development & Ethics Approval

Preparation of MOPH/PDCD-compatible protocol; securing IRB/Ethics Committee approval.

3. Analytical Method Development

Creation and validation of LC-MS/MS methods following ICH M10 & GCC standards.

4. Clinical Study Execution

Full GCP-compliant clinical operations: volunteer enrolment, dosing, sample collection, medical oversight.

5. Bioanalysis, PK & BE Statistics

Bioanalytical testing, QC, PK modelling, and BE statistical evaluation.

6. Documentation & Registration Support

CSRs, validation reports, dissolution profiling, and CTD modules packaged for MOPH/PDCD submission.

Who We Support in Qatar & GCC

• Generic drug manufacturers seeking Qatar drug product registration.

• GCC-focused pharmaceutical companies requiring BA/BE packages.

• CROs needing specialized analytical or clinical outsourcing.

• Regulatory teams preparing GCC-DR/CTD dossiers for submission to Qatar MOPH.