🇧🇹 Bioavailability & Bioequivalence (BA/BE) Studies Services for Bhutan
DRA-Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, offers complete BA/BE study services and Comparative Dissolution Profiling tailored for Bhutan’s regulatory requirements, governed by the Drug Regulatory Authority (DRA) of Bhutan.
All studies adhere to GCP, GLP, WHO TRS, ICH guidelines, and principles recognized by the DRA’s Medicines Rules & Regulations of Bhutan (MRR-B) to support pharmaceutical companies in achieving Bhutanese market approvals and international submissions.
💊 Our Core Services for Bhutan Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Design: Single-dose/multiple-dose BA/BE studies using crossover or parallel designs, aligned with international BA/BE standards recognized by the DRA.
• Volunteer Selection: Healthy volunteer or patient-based studies when required by the study protocol.
• Ethics Approval: Study approval through a registered Institutional Ethics Committee (IEC) compliant with Bhutan’s ethical and biomedical research frameworks.
• Protocol Development: Protocols designed using ICH E6 (R2) GCP, WHO TRS, and globally harmonized BA/BE guidance accepted by the DRA.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic product registration, variations, and post-approval changes in accordance with DRA standards.
• Media: Biorelevant and standard pharmacopeial dissolution media.
• Analysis: Calculation of f2 similarity factor for demonstrating dissolution similarity.
• Comparison Methods: Includes both model-independent (f1, f2) and model-dependent dissolution evaluation methods.
IVIVC & Biowaiver Support
• Biowaiver Justification: Preparation of BCS-based biowaiver documentation following WHO TRS and ICH framework accepted by the DRA.
• IVIVC Modeling: Level A, B, and C modeling for biopharmaceutics and regulatory evaluation.
• Predictive Modeling: Dissolution–PK simulation and justification.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV-based methods suitable for Bhutan BA/BE requirements.
• Validation: Method validation following ICH M10, WHO, and internationally harmonized bioanalytical standards.
• Stability Studies: Stability-indicating method development for APIs and drug products.
Pharmacokinetic (PK) Analysis
• PK Modeling: Non-compartmental analysis for all BA/BE study types.
• Statistical BE Assessment: Bioequivalence statistics aligned with ICH, WHO, and accepted international regulations.
• Design Optimization: Power and sample-size calculations based on DRA-accepted statistical norms.
📑 DRA-Ready Regulatory Documentation
We prepare complete documentation tailored for submission to the Drug Regulatory Authority (DRA), Bhutan:
• Clinical Study Protocol (DRA-aligned)
• Informed Consent Forms (ICF) compliant with Bhutanese research ethics
• Investigator Brochure
• Clinical Study Report (CSR) as per ICH and WHO structure accepted by the DRA
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD modules formatted for Bhutan drug registration applications
✨ Why Choose BioEquiGlobal for the Bhutan Market?
• Bhutan-Focused Regulatory Alignment: Protocols and documentation structured according to DRA expectations and WHO/ICH harmonized guidance adopted by Bhutan.
• Global Quality Compliance: GCP- and GLP-driven operations with SOP-based QA processes.
• Advanced Infrastructure: Accredited clinical facilities and analytical laboratories (including NABL-certified labs where applicable).
• International Dossier Strength: Preparation of regulatory submissions not only for Bhutan DRA but also for US FDA, EMA, GCC, MHRA, TGA, and other global agencies.
🗺️ Our BA/BE Study Workflow for Bhutan
Feasibility & Regulatory Gap Assessment: Evaluation of reference product availability, BCS class, and biowaiver acceptability under DRA/WHO guidance.
Protocol Development: Drafting of a DRA-aligned BA/BE protocol and obtaining ethics committee approval.
Analytical Method Development: LC-MS/MS method development and validation per ICH M10 and international requirements.
Clinical Execution: Dosing, sampling, and monitoring of volunteers under strict GCP conditions.
Bioanalysis & PK Assessment: Full bioanalytical testing, PK modeling, QC review, and statistical BE evaluation.
Documentation & Submission: Development of DGRA-compatible CSR, analytics documents, dissolution reports, and CTD/ACTD dossier modules.
Who We Support
• Bhutan pharmaceutical importers and manufacturers seeking DRA registration
• CROs requiring BA/BE or analytical outsourcing support
• Regulatory teams needing DRA-aligned CTD/ACTD documentation for submission