🇸🇪 Bioavailability & Bioequivalence (BA/BE) Studies Services for Sweden

MPA (Läkemedelsverket) & EMA-Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, offers comprehensive Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling, designed specifically to meet the regulatory expectations of Sweden and the wider European Union (EU).

All study activities comply with:

• Swedish Medical Products Agency (MPA / Läkemedelsverket)

• 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.)

Sweden is recognized for its world-class clinical research infrastructure, strict regulatory oversight, and high standards of scientific quality — making it an excellent environment for BA/BE studies intended for EU-wide approval.

💊 Core BA/BE Services for Sweden & EMA Submissions

Clinical BA/BE Studies (Human)

• Conducted according to MPA, EMA, and EU-GCP requirements.
• Single-dose & multiple-dose BE studies with crossover or parallel designs.
• Studies in healthy volunteers or relevant patient groups depending on indication.
• Ethical approval through Swedish Ethical Review Authority under EU-CTR 536/2014.
• Protocols developed in alignment with ICH E6 (R2) and EMA bioequivalence guidelines.

Comparative Dissolution Profiling (CDP)

• Required for EU generic submissions (Article 10).
• Dissolution performed using Ph. Eur., USP, and biorelevant media.
• Similarity factor (f2) used to compare dissolution profiles.
• Kinetic (model-dependent) & model-independent analyses performed as needed.

IVIVC & Biowaiver Support

• EMA-accepted BCS-based biowaiver preparation for suitable APIs.
• Level A/B/C IVIVC modeling for biopredictive dissolution-PK relationships.
• Biowaiver eligibility for BCS Class I & III products under EMA guidance.

Analytical Method Development & Validation

• LC-MS/MS & HPLC-UV analytical methods.
• Full validation per ICH M10, accepted by MPA & all EU regulators.
• Stability-indicating methods for APIs & finished formulations.
• Precision, accuracy, linearity, specificity & stability established.

Pharmacokinetic (PK) & Bioequivalence Statistical Analysis

• Non-compartmental PK analysis (AUC, Cmax, Tmax, t½).
• EMA BE acceptance limits: 90% CI within 80.00–125.00%.
• Scaled BE methodologies for Highly Variable Drugs (HVDs).
• Sample-size & power optimization following EMA statistical requirements.

📑 MPA- & EMA-Ready CTD Documentation

We prepare complete EU CTD documentation packages:

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

• EU Generic Applications (Article 10)

• Decentralized Procedure (DCP)

• Mutual Recognition Procedure (MRP)

• Centralized Procedure (CP)

✨ Why Choose BioEquiGlobal for Sweden?

• World-Class Research Environment: Sweden’s clinical research centers offer exceptional quality & regulatory compliance.
• EMA-Aligned BE Expertise: Ensures EU-wide acceptability of study data.
• High Regulatory Integrity: Strict adherence to GCP/GLP/GMP ensures global-quality standards.
• Ideal for Complex Generics: Sweden supports advanced studies (HVDs, MR formulations, topicals, injectables, etc.).
• End-to-End Support: From feasibility to PK/BE assessment and complete CTD submission.

🗺️ BA/BE Study Workflow for Sweden / EU Sponsors

1. Feasibility & Regulatory Assessment
   (Reference product selection, EMA BE mapping, biowaiver evaluation)

2. Protocol Development & Ethical Approval
   (Submission to Swedish Ethical Review Authority under EU-CTR)

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

4. Clinical Study Execution in Sweden
   (Volunteer recruitment, dosing, PK sampling, quality oversight)

5. Bioanalysis & PK/BE Evaluation
   (NCA, statistical BE evaluation, scaled BE where appropriate)

6. CTD Documentation Preparation
   (CSR, CDP, validation reports & CTD Modules)

Who We Support in Sweden & Across Europe

• EU generic drug manufacturers
• MAH applicants using DCP, MRP, or CP procedures
• CROs requiring BA/BE or analytical outsourcing
• R&D centers reformulating existing EU-marketed medicines
• Export-oriented pharmaceutical manufacturers entering EU markets
• Biotech & specialty pharma companies