🇨🇭 Bioavailability & Bioequivalence (BA/BE) Studies Services for Switzerland

Swissmedic-Compliant BA/BE Studies & Comparative Dissolution Profiling — By BioEquiGlobal

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, delivers complete Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling tailored for pharmaceutical submissions to Swissmedic, the Swiss Agency for Therapeutic Products.

Switzerland is not part of the EU regulatory network; however, Swissmedic relies heavily on ICH standards and recognizes scientific principles from EMA and WHO for BE evaluation.

Our services comply with:

• Swissmedic Guidance for Authorisation of Human Medicines

• Swissmedic Bioequivalence Requirements (aligned with EMA/ICH principles)

• ICH Guidelines (E6 R2, E8, Q2, Q6A, M10)

• WHO BE Guidelines & internationally harmonized standards

• GCP, GLP & GMP quality systems

• Ph. Eur. / USP dissolution specifications

Switzerland is known for strict regulatory scrutiny, high scientific expectations, and excellent clinical research quality—making accurate BE design essential.

💊 Core BA/BE Services for Switzerland (Swissmedic-Aligned)

Clinical BA/BE Studies (Human)

• Designed according to Swissmedic BE expectations & ICH GCP.
• Single-dose & multiple-dose BE studies in crossover or parallel design.
• Studies in healthy volunteers or relevant patient groups.
• Ethical approval via Swiss Ethics Committees (Swissethics).
• BE protocols aligned with EMA/ICH PK guidelines for Swissmedic acceptance.

Comparative Dissolution Profiling (CDP)

• Required for generic and line extension applications.
• Dissolution per Ph. Eur., USP, and biorelevant media.
• Similarity factor (f2) analysis for dissolution comparability.
• Model-independent & model-dependent dissolution comparisons.

IVIVC & Biowaiver Support

• BCS-based biowaiver justification accepted by Swissmedic when aligned with EMA/ICH principles.
• IVIVC modeling (Level A/B/C) for mechanistic understanding of PK–dissolution correlation.
• Biowaiver support for BCS Class I & III compounds where applicable.

Analytical Method Development & Validation

• LC-MS/MS & HPLC-UV bioanalytical and dissolution method development.
• Validation performed per ICH M10, accepted by Swissmedic.
• Stability-indicating analytical methods for APIs & finished dosage forms.
• Complete validation: accuracy, precision, linearity, selectivity, and stability.

Pharmacokinetic (PK) & BE Statistical Analysis

• Non-compartmental PK calculation (AUC, Cmax, Tmax, t½).
• BE acceptance ranges similar to EMA: 90% CI within 80–125%.
• Handling of Highly Variable Drugs (HVDs) using scientifically justified scaling strategies.
• Robust sample-size & statistical power calculations.

📑 Swissmedic-Ready CTD Documentation

We prepare full CTD documentation packages tailored to Swiss submission requirements:

• Clinical Study Protocol
• Informed Consent Form (ICF)
• Investigator Brochure
• Clinical Study Report (CSR) per ICH E3 / Swissmedic expectations
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile (CDP) Report
• Swiss CTD Modules 1–5, including:

• Module 1 adapted to Swissmedic requirements

• Generic drug submissions

• Variations requiring BE support

✨ Why Choose BioEquiGlobal for Switzerland?

• Swissmedic-Aligned Expertise: BE study design and documentation meet Switzerland’s high regulatory standards.
• Global Acceptability & Precision: GCP/GLP/GMP-aligned operations ensure high-quality, globally viable BE data.
• Advanced Scientific Capabilities: Suitable for complex generics (MR, HVDs, topicals, injectables, ophthalmic & inhalation products).
• Ideal for Europe + Global Markets: BE packages prepared for Switzerland can easily be extended for EU, UK, GCC, TGA, USFDA and other regions.
• End-to-End Support: From feasibility assessment to PK/BE analysis and complete CTD dossier preparation.

🗺️ BA/BE Study Workflow for Switzerland

1. Feasibility & Regulatory Mapping
   (Reference product identification, Swissmedic/ICH guideline alignment)

2. Protocol Development & Swissethics Approval
   (ICH GCP-compliant documentation)

3. Bioanalytical Method Development & Validation
   (ICH M10 compliance)

4. Clinical BA/BE Study Execution
   (GCP-supervised dosing, sampling & safety monitoring)

5. Bioanalysis & PK/BE Evaluation
   (NCA modeling, BE assessment)

6. Swissmedic-Ready CTD Documentation
   (CSR, CDP, validation package & Module 1–5 CTD)

Who We Support in Switzerland & Internationally

• Swiss pharmaceutical manufacturers
• International companies entering the Swiss market
• CROs outsourcing PK, bioanalytical or clinical BE services
• Innovators reformulating products for Swiss regulatory pathways
• Export-focused pharmaceutical manufacturers requiring global-standard BE data
• Specialty pharma & biotech organizations