🇧🇷 Bioavailability & Bioequivalence (BA/BE) Studies Services for Brazil

🇧🇷 Bioavailability & Bioequivalence (BA/BE) Studies Services for Brazil

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

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt. Ltd., provides complete Bioavailability/Bioequivalence (BA/BE) study services and Comparative Dissolution Profiling (CDP) designed to meet the requirements of ANVISA, Brazil’s national regulatory authority.

Our studies strictly follow ANVISA Resolutions (RDCs), ICH, WHO TRS, GCP, and GLP, supporting pharmaceutical manufacturers seeking registration of generic (G), similar (S), and reference-equivalent medicines in Brazil.

💊 Core Services for Brazil (ANVISA)

1. Clinical BA/BE Studies (Human)

(Aligned with RDC 37/2011 & RDC 200/2017)

• Study Designs: Single-dose, multiple-dose, crossover & parallel designs as required by ANVISA.

• Volunteer Recruitment: Healthy volunteers under strict ICH-GCP conditions.

• Ethics Approval: Mandatory approval from CEP/CONEP (Comitê de Ética em Pesquisa / Comissão Nacional de Ética em Pesquisa).

• Protocol Development: Fully compliant with ANVISA norms and ICH E6 (R2).

2. Comparative Dissolution Profiling (CDP)

(Required for RDC 31/2010 + equivalence & waiver pathways)

• Dissolution Media: According to pharmacopoeial, biorelevant, and ANVISA-specific requirements.

• Similarity Evaluation: f2 similarity factor, kinetic modeling, and model-independent approaches.

• Purpose: Used for biowaivers, post-approval changes, comparative assessments for similar/generic drugs.

• Output: ANVISA-ready CDP report for CTD Module 3.

3. IVIVC & Biowaiver Support

• BCS Biowaiver: Prepared per ANVISA’s biopharmaceutics framework, WHO, and ICH Q6A.

• IVIVC Modeling: Level A, B & C models based on dissolution–PK correlation.

• Predictive Tools: In vitro–in vivo performance evaluation supporting regulatory acceptance.

4. Analytical Method Development & Validation

(Aligned with RDC 166/2017 – Bioanalytical Method Validation)

• Platforms: LC–MS/MS & HPLC-UV.

• Validation: Selectivity, sensitivity, accuracy, precision, stability per ANVISA & ICH M10.

• Stability Methods: Long-term, accelerated, in-process, and matrix stability.

5. Pharmacokinetic (PK) & Bioequivalence Statistics

• PK Analysis: Non-compartmental PK using validated tools.

• BE Statistics: CI-based evaluation for AUC, Cmax per RDC 37/2011.

• Sample Size & Power: Determined according to ANVISA’s BE variability requirements.

📑 Brazil (ANVISA)–Ready Regulatory Documentation

We prepare full documentation aligned with ANVISA CTD and specific RDCs, including:

• Clinical Study Protocol (Portuguese/English as needed)

• Informed Consent Forms (Portuguese required for human studies)

• Investigator’s Brochure

• Clinical Study Report (CSR) in ANVISA structure

• Bioanalytical Method Validation Report (RDC 166/2017 compliant)

• Comparative Dissolution Profiling Report

• CTD Modules 1–5 for ANVISA submission

• Templates required for Generic/Similar Drug Applications

✨ Why Choose BioEquiGlobal for Brazil?

• ANVISA Expertise: Deep experience with RDC 37/2011, RDC 166/2017, and Brazil’s generic/similar drug regulations.

• Strict Quality Systems: All studies follow ICH-GCP, GLP, WHO, and ANVISA bioequivalence norms.

• Accredited Clinical & Analytical Partners: Access to validated laboratories and GCP-compliant study centers.

• Regional Strength: Support for regulatory pathways across Brazil, LATAM, and global markets.

• End-to-End Services: From feasibility to CTD preparation and ANVISA submission.

🗺️ Our BA/BE Workflow for Brazil

1. Feasibility & RDC Gap Assessment

Analysis of ANVISA requirements, reference product availability, and Brazil-specific biowaiver rules.

2. Protocol Development & CEP/CONEP Ethics Approval

Preparation of compliant clinical protocols, consent forms, and ethics submission documents.

3. Analytical Method Development & Validation

LC–MS/MS method development and full validation per RDC 166/2017 & ICH M10.

4. Clinical Study Execution

Volunteer screening, dosing, sample collection, and safety monitoring under GCP.

5. Bioanalysis, PK & BE Evaluation

Bioanalytical testing, PK calculation, and ANVISA-approved statistical comparisons.

6. Documentation & ANVISA Submission

Preparation of CSR, CDP, CTD modules, and submission-ready dossier for ANVISA.

Who We Support in Brazil & Latin America

• Generic and similar-drug manufacturers submitting to ANVISA.

• Regional pharmaceutical companies targeting Brazil’s regulated market.

• CROs requiring analytical or clinical outsourcing for BA/BE studies.

• Regulatory affairs teams preparing CTD/ACTD dossiers.