🇳🇴 Bioavailability & Bioequivalence (BA/BE) Studies Services for Norway

NoMA (Norwegian Medicines Agency) & EMA-Compliant BA/BE Studies — 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 expectations of Norway (NoMA) and the wider European Economic Area (EEA)/European Union (EU).

All study activities comply with:

• NoMA (Norwegian Medicines Agency) clinical trial & BE requirements

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

• EU Clinical Trial Regulation (CTR) 536/2014 — applicable through EEA alignment

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

• EU-GCP, EU-GLP & EU-GMP (Annex 13)

• European Pharmacopoeia (Ph. Eur.)

Although Norway is not an EU member, it fully aligns with EMA and EU medicinal product regulations under EEA agreements, making BE studies conducted for Norway suitable for EU-wide submissions.

💊 Core BA/BE Services for Norway & EEA/EMA Submissions

Clinical BA/BE Studies (Human)

• Conducted per NoMA, EMA, and EU-GCP standards.
• Single-dose and multiple-dose BE studies (crossover or parallel designs).
• Studies conducted on healthy volunteers or relevant patient groups.
• Ethical approval via Regional Committees for Medical and Health Research Ethics (REK).
• Protocols developed according to ICH E6 (R2) and EMA BE requirements.

Comparative Dissolution Profiling (CDP)

• Required for generic submissions under EEA/EU Directive 2001/83/EC (Article 10).
• Dissolution performed using Ph. Eur., USP, and biorelevant media (FaSSIF/FeSSIF).
• Similarity factor (f2) evaluation for dissolution equivalence.
• Supports both model-independent & model-dependent release profiling.

IVIVC & Biowaiver Support

• BCS-based biowaiver preparation aligned with EMA guidance & ICH Q6A.
• Level A/B/C IVIVC modeling for PK-dissolution correlation.
• Biowaiver suitability assessment for BCS Class I & III drug products.

Analytical Method Development & Validation

• Bioanalytical method development via LC-MS/MS & HPLC-UV.
• Complete validation as per ICH M10, recognized by NoMA & EMA.
• Stability-indicating methods for APIs & finished pharmaceutical products.
• Full validation coverage: accuracy, precision, selectivity, linearity & stability.

Pharmacokinetic (PK) & BE Statistical Evaluation

• Non-compartmental PK analysis (AUC, Cmax, Tmax, t½).
• EMA-standard BE acceptance limits: 90% CI within 80.00–125.00%.
• Scaled BE for Highly Variable Drugs (HVDs) when permissible.
• Statistical power & sample-size calculations following EMA guidance.

📑 NoMA- & EMA-Ready CTD Documentation

We prepare complete regulatory packages compliant with Norway, EEA & EU requirements:

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

• Generic submissions (Article 10)

• Decentralized Procedure (DCP)*

• Mutual Recognition Procedure (MRP)*

• Centralized Procedure (CP)
  *Note: Norway participates in DCP/MRP as an EEA member.

✨ Why Choose BioEquiGlobal for Norway?

• EEA Regulatory Alignment: BE studies designed for Norway are acceptable across the EU/EEA under harmonized EMA standards.
• High-Quality Research Environment: Norway’s hospitals and research centers deliver exceptional trial conduct and data integrity.
• Rigorously GCP/GLP/GMP-Compliant: Ensures acceptance in international markets, including EU, UK, Canada, and Australia.
• Comprehensive Support for Generics & Complex Products: Including modified-release, HVDs, topicals, and sterile formulations.
• End-to-End BE Solutions: From pre-study feasibility to full CTD dossier preparation.

🗺️ BA/BE Study Workflow for Norway / EEA Sponsors

1. Feasibility Assessment & EMA Mapping
   (Reference product verification, BE strategy, biowaiver eligibility)

2. Protocol Development & Ethics Approval
   (Submission to REK under EU-CTR structure)

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

4. Clinical Study Execution in Norway
   (GCP-compliant recruitment, dosing, PK sampling & safety monitoring)

5. Bioanalysis & PK/BE Evaluation
   (NCA, BE statistics, scaled BE for HVDs)

6. CTD Documentation for NoMA & EMA
   (CSR, CDP, validation documents & CTD Modules)

Who We Support in Norway & Across the EU/EEA

• Generic pharmaceutical manufacturers
• Marketing Authorization Holders (MAHs) filing via DCP, MRP & CP
• CROs outsourcing PK/bioanalytical or BE operations
• R&D units reformulating authorized medicines
• Export-oriented pharmaceutical companies targeting EEA/EU
• Specialty pharma & biotechnology organizations