🇱🇰 Bioavailability & Bioequivalence (BA/BE) Studies Services for Sri Lanka
NMRA-Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, offers comprehensive Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling tailored to the regulatory requirements of the National Medicines Regulatory Authority (NMRA), Sri Lanka.
All studies strictly follow NMRA guidelines, ICH, WHO TRS, GCP, GLP, and international regulatory standards to support Sri Lankan pharmaceutical submissions and global market approvals.
💊 Core Services for Sri Lanka (NMRA) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BA/BE studies using crossover or parallel designs approved by NMRA.
• Volunteer Selection: Healthy volunteers or patient-based studies depending on therapeutic class and NMRA expectations.
• Ethics Approval: Required approval from a Sri Lanka–registered Ethics Review Committee (ERC).
• Protocol Development: NMRA-aligned BA/BE protocols based on ICH E6 (R2) GCP and WHO TRS recommendations.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Needed for generic product registration, dossier variations, and post-approval changes.
• Testing Media: Biorelevant and pharmacopeial dissolution media.
• Similarity Factor: f2 similarity factor analysis for comparing test vs. reference products.
• Evaluation Models: Model-independent (f1, f2) and model-dependent dissolution modeling.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Developed according to WHO TRS, ICH Q6A, and principles recognized by NMRA.
• IVIVC Modeling: Level A, B, and C correlation models.
• Predictive PK Modeling: Linking dissolution data with expected in vivo performance.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV systems for robust drug quantification.
• Validation: Conducted as per ICH M10, WHO TRS, and NMRA-accepted analytical standards.
• Stability Methods: Stability-indicating methods for APIs and finished dosage forms.
Pharmacokinetic (PK) Analysis
• PK Methodology: Non-compartmental analysis (NCA) for BA/BE assessments.
• BE Statistics: Performed according to ICH and WHO statistical frameworks recognized by NMRA.
• Power Analysis: Sample-size determination and study design optimization.
📑 NMRA-Ready Regulatory Documentation
We prepare complete documentation required for submission to the National Medicines Regulatory Authority (NMRA), Sri Lanka, including:
• Clinical Study Protocol (NMRA-compliant)
• Informed Consent Forms (ICF) in line with ERC requirements
• Investigator Brochure
• Clinical Study Report (CSR) formatted per ICH/WHO TRS
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules for Sri Lanka NMRA drug registration
✨ Why Choose BioEquiGlobal for the Sri Lankan Market?
• Regulatory Precision: Protocols, CDP reports, PK analyses, and dossiers tailored to NMRA expectations.
• Quality Assurance: GCP-, GLP-, ICH-, and WHO-compliant operations with SOP-driven internal QA oversight.
• Advanced Facilities: Accredited clinical units and high-performance analytical laboratories (including NABL-certified labs where applicable).
• Global Dossier Expertise: Preparation of submission-ready CTD/ACTD files for NMRA and authorities such as US FDA, EMA, MHRA, TGA, GCC, ASEAN regulators, and African agencies.
🗺️ BA/BE Study Workflow for Sri Lanka
Feasibility & Gap Assessment: Evaluation of Sri Lankan reference products, dissolution methods, and biowaiver eligibility.
Protocol Development: Drafting NMRA-compliant BA/BE protocols and securing ERC approval.
Analytical Method Development: LC-MS/MS method creation and validation per ICH M10 and WHO TRS guidelines.
Clinical Execution: GCP-monitored volunteer dosing, sampling, and safety evaluation.
Bioanalysis & PK Evaluation: QC-verified bioanalysis, PK computation, and BE statistical assessment.
Documentation & Submission: Preparation of NMRA-ready CSR, dissolution reports, validation documentation, and CTD/ACTD modules.
Who We Support
• Sri Lankan pharmaceutical manufacturers seeking NMRA drug registration
• CROs requiring BA/BE outsourcing or analytical support
• Regulatory affairs teams needing NMRA-compliant CTD/ACTD dossiers