🇱🇻 Bioavailability & Bioequivalence (BA/BE) Studies Services for Latvia

ZVA & EMA-Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, delivers comprehensive Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling tailored to the regulatory expectations of Latvia and the wider European Union (EU).

All studies and documentation comply with:

• ZVA (State Agency of Medicines of Latvia) requirements

• EMA Guideline on the Investigation of Bioequivalence (2010/2022 Update)

• EU Clinical Trial Regulation (CTR) 536/2014

• ICH Guidelines (E6 R2, Q2, Q6A, M10)

• EU-GCP, EU-GLP & EU-GMP (Annex 13)

• European Pharmacopoeia (Ph. Eur.)

Latvia is an emerging Baltic hub for clinical research, offering efficient ethics review processes and high-quality clinical trial execution aligned with EU standards.

💊 Core BA/BE Services for Latvia & EMA Submissions

Clinical BA/BE Studies (Human)

• Conducted according to ZVA, EMA & EU-GCP guidelines.
• Single-dose and multiple-dose BE studies (crossover or parallel).
• Healthy volunteer or patient-based studies depending on the product.
• Ethical approval from Latvian Ethics Committees under EU-CTR 536/2014.
• Protocols designed according to ICH E6 (R2) & EMA BE guidance.

Comparative Dissolution Profiling (CDP)

• Required for all EU generic applications (Article 10 of Directive 2001/83/EC).
• Dissolution testing per Ph. Eur., USP, EP & biorelevant media.
• f2 similarity factor analysis for dissolution comparability.
• Model-independent & kinetic (model-dependent) dissolution assessment.

IVIVC & Biowaiver Support

• BCS-based biowaiver justification aligned with EMA BCS-based biowaiver guidelines & ICH Q6A.
• Level A/B/C IVIVC modeling for supportive PK prediction.
• Waiver eligibility for BCS Class I & III compounds under EU criteria.

Analytical Method Development & Validation

• LC-MS/MS and HPLC-UV method development and validation.
• Validation per ICH M10, accepted by ZVA & EMA.
• Stability-indicating methods for APIs and finished drug products.
• Full validation: precision, accuracy, stability, selectivity & linearity.

Pharmacokinetic (PK) & BE Statistical Analysis

• Non-compartmental PK analysis per EMA requirements.
• BE acceptance limits: 90% CI within 80.00–125.00%.
• Scaled BE approaches for Highly Variable Drugs (HVDs).
• Dose proportionality, variability analysis & power/sample-size optimization.

📑 ZVA- & EMA-Ready CTD Documentation

We prepare complete EU CTD documentation ready for submission in Latvia and throughout the EU:

• Clinical Study Protocol
• Informed Consent Form (ICF)
• Investigator Brochure
• Clinical Study Report (CSR) as per EMA & ICH E3
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD Modules 1–5 for:

• Generic applications (Article 10)

• Decentralized Procedure (DCP)

• Mutual Recognition Procedure (MRP)

• Centralized Procedure (CP)

✨ Why Choose BioEquiGlobal for Latvia?

• Strong Baltic Clinical Trial Ecosystem: Latvia offers efficient ethics review and high-quality clinical infrastructures.
• EMA-Focused Study Design: All BE methodologies follow EMA standards, allowing EU-wide acceptance.
• High Regulatory Compliance: Strict adherence to EU-GCP, GLP & GMP ensures data validity for multiple regions.
• Seamless EU Integration: Latvia-based BE data is fully valid across all EU and EEA regulatory pathways.
• Comprehensive Service: From feasibility and BE planning to PK analysis & full CTD dossier preparation.

🗺️ BA/BE Study Workflow for Latvia / EU Sponsors

1. Feasibility & Regulatory Evaluation
   (Reference product identification, biowaiver feasibility, EMA guideline mapping)

2. Protocol Development & Ethics Submission
   (Ethics Committee submission in Latvia under EU-CTR)

3. Analytical Method Development & Validation
   (ICH M10-compliant LC-MS/MS validation)

4. Clinical Study Execution in Latvia
   (GCP-compliant dosing, sampling, safety monitoring)

5. Bioanalysis, PK Modeling & BE Statistics
   (NCA, BE assessment, scaled BE for HVDs)

6. Complete CTD Documentation for ZVA/EMA
   (CSR, dissolution report, validation documents & CTD modules)

Who We Support in Latvia & Across Europe

• Generic pharmaceutical manufacturers (Article 10 applicants)
• MAH holders using DCP, MRP, or CP pathways
• CROs handling outsourced bioanalytical or PK/BE operations
• R&D units reformulating EU-authorized medicines
• Export-oriented pharmaceutical manufacturers entering EU markets
• Biotech & specialty pharma innovators