Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Turkmenistan

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

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides complete Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling aligned with the regulatory requirements of the Ministry of Health and Medical Industry of Turkmenistan (MoHMI) and the State Service for Supervision of Medicines and Medical Equipment.

All studies strictly follow MoHMI regulations, ICH standards, WHO TRS, GCP, and GLP, ensuring readiness for Turkmenistan drug registration and international regulatory submissions.

💊 Core Services for Turkmenistan (MoHMI) Regulatory Submissions

Clinical BA/BE Studies (Human)

• Study Designs: Single-dose & multiple-dose BA/BE studies using crossover or parallel designs recognized by Turkmen regulators.
• Volunteer Selection: Healthy volunteers or patient groups depending on therapeutic requirements.
• Ethics Approval: Required approval from a Turkmenistan-recognized Ethics Committee/IRB.
• Protocol Development: Aligned with ICH E6 (R2) GCP, WHO TRS, and MoHMI expectations.

Comparative Dissolution Profiling (CDP)

• Regulatory Requirement: Required for generic submissions, formulation modifications, and BE justification.
• Dissolution Media: Pharmacopeial and biorelevant dissolution media.
• Similarity Factor: f2 similarity factor for dissolution profile comparison.
• Evaluation Approaches: Model-independent (f1, f2) and model-dependent methods aligned with WHO/ICH principles.

IVIVC & Biowaiver Support

• BCS-Based Biowaiver: Prepared according to WHO TRS, ICH Q6A, and MoHMI-recognized scientific justifications.
• IVIVC Models: Level A, B, and C in vitro–in vivo correlation models.
• Predictive PK Modeling: Supports regulatory decisions for biowaivers and BE study strategies.

Analytical Method Development & Validation

• Platforms: LC-MS/MS and HPLC-UV analytical systems.
• Validation: Conducted per ICH M10, WHO TRS, and standards compatible with Turkmenistan regulatory expectations.
• Stability-Indicating Methods: Developed for APIs and finished pharmaceutical products.

Pharmacokinetic (PK) Analysis

• PK Methodology: Non-compartmental analysis (NCA).
• BE Statistics: Performed using ICH- and WHO-harmonized methods accepted by MoHMI.
• Sample Size & Power: Determined scientifically for reliable BE outcomes.

📑 Turkmenistan MoHMI–Ready Regulatory Documentation

We prepare comprehensive regulatory documentation suitable for submission to Turkmenistan’s Ministry of Health and Medical Industry, including:

• Clinical Study Protocol (Turkmenistan-compliant)
• Informed Consent Forms (ICF) aligned with national ethics requirements
• Investigator Brochure
• Clinical Study Report (CSR) per ICH & WHO TRS
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules (1–5) formatted for Turkmenistan submissions

✨ Why Choose BioEquiGlobal for the Turkmen Market?

• Turkmenistan Expertise: BE protocols, PK reports, dissolution studies, and CTD dossiers tailored to MoHMI requirements.
• International Quality Standards: Full compliance with GCP, GLP, WHO TRS, and ICH guidelines supported by robust QA systems.
• Advanced Clinical & Analytical Infrastructure: Accredited clinical units and modern analytical laboratories (including NABL-certified labs).
• Global Regulatory Capability: CTD/ACTD dossier preparation for Turkmenistan and major agencies (US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.).

🗺️ BA/BE Study Workflow for Turkmenistan

1. Feasibility & Gap Assessment: Evaluation of reference product availability, dissolution requirements, and biowaiver potential.

2. Protocol Development: Drafting MoHMI-compliant BA/BE protocols and supporting Ethics Committee submission.

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

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

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

6. Documentation & Submission: Preparation of Turkmenistan-ready CSR, dissolution profile, validation package, and CTD/ACTD modules.

Who We Support

• Pharmaceutical companies targeting Turkmenistan
• CROs requiring BA/BE outsourcing or analytical method support
• Regulatory teams needing MoHMI-compliant CTD/ACTD dossiers