🇵🇾 Bioavailability & Bioequivalence (BA/BE) Studies Services for Paraguay

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

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt. Ltd., offers comprehensive Bioavailability/Bioequivalence (BA/BE) study services and Comparative Dissolution Profiling (CDP) aligned with the regulatory requirements of Paraguay’s DINAVISA (Dirección Nacional de Vigilancia Sanitaria).

Our studies follow MERCOSUR technical regulations, WHO TRS, ICH, GCP, and GLP—supporting pharmaceutical companies seeking registration of generic and similar medicines in Paraguay and broader South America.

💊 Core Services for Paraguay (DINAVISA / MERCOSUR)

1. Clinical BA/BE Studies (Human)

(Aligned with MERCOSUR Resolutions & WHO/ICH GCP guidelines)

• Study Designs: Single-dose and multiple-dose, crossover & parallel designs acceptable to DINAVISA.

• Volunteers: Healthy volunteer recruitment under strict ICH-GCP oversight.

• Ethics Approval: Required from a Paraguayan Comité de Ética en Investigación recognized by MSPBS.

• Study Protocol: Prepared according to ICH E6 (R2), WHO BA/BE, and MERCOSUR harmonized guidelines.

2. Comparative Dissolution Profiling (CDP)

(Mandatory for formulation comparison and biowaiver justification)

• Dissolution Media: Biorelevant and pharmacopoeial media (USP/Ph.Eur.) following MERCOSUR/WHO expectations.

• Similarity Evaluation: f2 similarity factor, kinetic and model-based analysis.

• Reporting: Fully aligned with DINAVISA requirements and CTD Module 3 standards.

3. IVIVC & Biowaiver Support

• BCS-Based Biowaiver: Prepared according to WHO, ICH Q6A, and MERCOSUR regional norms.

• IVIVC Models: Level A, B & C correlations.

• Predictive Tools: Modeling dissolution–PK relationships for waiver justification during DINAVISA review.

4. Analytical Method Development & Validation

• Platforms: LC-MS/MS and HPLC-UV.

• Validation: According to ICH M10 and WHO bioanalytical principles.

• Stability Studies: Stability-indicating methods for APIs and finished dosage forms.

5. Pharmacokinetic (PK) & Bioequivalence Statistics

• PK Modeling: Non-compartmental analysis (NCA).

• BE Statistics: Confidence interval evaluation (AUC, Cmax) per MERCOSUR/WHO/ICH norms.

• Sample Size: Determined using BE variance and DINAVISA-acceptable power criteria.

📑 Paraguay (DINAVISA)–Ready Regulatory Documentation

We prepare complete, submission-ready documentation bundles compatible with DINAVISA and MERCOSUR CTD formats, including:

• Clinical Study Protocol

• Informed Consent Forms (Spanish required)

• Investigator’s Brochure

• Clinical Study Report (CSR) aligned with DINAVISA standards

• Bioanalytical Method Validation Report

• Comparative Dissolution Profile Report

• CTD/ACTD Modules (1–5)

• Required DINAVISA administrative & regulatory submission templates

✨ Why Choose BioEquiGlobal for Paraguay?

• Regulatory Alignment: Expertise in DINAVISA guidelines and MERCOSUR harmonized regulations.

• High Quality Standards: GCP, GLP, WHO, and ICH compliant processes.

• Modern Infrastructure: Access to accredited clinical facilities and validated analytical laboratories.

• Regional Reach: Support for Paraguay, Argentina, Uruguay, Brazil, Chile, and broader LATAM submissions.

• Global Preparation: Dossier readiness for EMA, FDA, GCC, India, AU-AMA, and other global regulatory agencies.

🗺️ Our BA/BE Workflow for Paraguay

1. Feasibility & Regulatory Gap Assessment

Evaluation of reference product, BCS class, MERCOSUR requirements, and DINAVISA dossier needs.

2. Protocol Development & Ethics Approval

Preparation of WHO/ICH-compliant protocol and securing approval from Paraguayan CEI.

3. Analytical Method Development & Validation

ICH M10–validated LC-MS/MS method development and stability studies.

4. Clinical Study Execution

Volunteer recruitment, dosing, blood sampling, and safety monitoring per ICH-GCP.

5. Bioanalysis, PK & BE Evaluation

Bioanalytical data processing, PK modeling, BE comparisons, and QC checks.

6. Documentation & Submission to DINAVISA

Finalization of CSR, CDP reports, and complete CTD dossier assembly.

Who We Support in Paraguay & LATAM

• Manufacturers seeking DINAVISA approval for generic/similar drugs

• Companies targeting MERCOSUR markets (Paraguay, Argentina, Uruguay, Brazil)

• CROs outsourcing BA/BE analytical or clinical phases

• Regulatory teams preparing CTD/ACTD dossiers