🇵🇪 Bioavailability & Bioequivalence (BA/BE) Studies Services for Peru

DIGEMID–Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, delivers comprehensive Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling aligned with Peru’s pharmaceutical regulatory requirements under:

• DIGEMID – Dirección General de Medicamentos, Insumos y Drogas

• Ministerio de Salud del Perú (MINSA)

All studies strictly comply with DIGEMID regulatory standards, ICH guidelines, WHO TRS, GCP, and GLP, ensuring full suitability for national drug registration and broader Latin American submissions.

💊 Core Services for Peru (DIGEMID / MINSA) Regulatory Submissions

Clinical BA/BE Studies (Human)

• Study Designs: Single-dose & multiple-dose crossover or parallel BE study designs recognized by DIGEMID.
• Volunteer Selection: Healthy adults or patient groups depending on therapeutic classification.
• Ethics Approval: Required approval from a Comité Institucional de Ética en Investigación (CIEI) accredited in Peru.
• Protocol Development: Created in accordance with ICH E6 (R2) GCP, WHO TRS, and DIGEMID’s BE guidelines.

Comparative Dissolution Profiling (CDP)

• Regulatory Requirement: Mandatory for generics, post-registration changes, and pharmaceutical equivalence assessments.
• Dissolution Media: Pharmacopeial and biorelevant media accepted by DIGEMID.
• Similarity Factor: f2 similarity factor to compare dissolution curves.
• Evaluation Models: WHO/ICH-compliant model-independent (f1, f2) and model-dependent dissolution analyses.

IVIVC & Biowaiver Support

• BCS-Based Biowaiver: Prepared according to WHO TRS, ICH Q6A, and DIGEMID biowaiver criteria.
• IVIVC Models: Level A, B, and C in vitro–in vivo correlation modeling.
• Predictive PK Modeling: Supports biowaiver justification and optimized regulatory strategy.

Analytical Method Development & Validation

• Platforms: LC-MS/MS and HPLC-UV analytical technologies.
• Validation: Conducted per ICH M10, WHO TRS, and DIGEMID-accepted validation standards.
• Stability-Indicating Methods: Designed for APIs and finished dosage forms.

Pharmacokinetic (PK) Analysis

• PK Method: Non-compartmental analysis (NCA).
• BE Statistics: Performed using WHO/ICH harmonized statistical procedures.
• Sample Size & Power: Scientifically determined for robust BE outcomes.

📑 Peru DIGEMID–Ready Regulatory Documentation

We prepare complete documentation tailored for DIGEMID submissions, including:

• Clinical Study Protocol (Peru-compliant)
• Informed Consent Forms (ICF) meeting ethical requirements of CIEI
• Investigator Brochure
• Clinical Study Report (CSR) per WHO TRS & ICH format
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules (1–5) formatted specifically for DIGEMID regulatory filing

✨ Why Choose BioEquiGlobal for the Peruvian Market?

• Regulatory Expertise: BE protocols, CDP reports, validation documents, and CTD dossiers tailored for DIGEMID.
• Global-Standard Compliance: Strict adherence to GCP, GLP, WHO TRS, and ICH guidelines with robust QA oversight.
• Advanced Research Infrastructure: Accredited clinical centers and modern analytical laboratories (including NABL-certified labs).
• International Submission Capability: CTDs prepared for Peru and major global authorities (US FDA, EMA, MHRA, TGA, SAHPRA, GCC, etc.).

🗺️ BA/BE Study Workflow for Peru

1. Feasibility & Gap Assessment: Evaluation of reference drug availability, dissolution comparability, and biowaiver potential.

2. Protocol Development: Drafting DIGEMID-compliant BA/BE protocols and coordinating CIEI approval.

3. Analytical Method Development: LC-MS/MS method development & validation per ICH M10 & WHO TRS.

4. Clinical Study Execution: GCP-monitored volunteer recruitment, dosing, PK sampling, and medical supervision.

5. Bioanalysis & PK Evaluation: PK modeling, QC checks, and statistical BE interpretation.

6. Documentation & Submission: Preparation of DIGEMID-ready CSR, CDP report, validation package, and CTD/ACTD modules.

Who We Support

• Pharmaceutical companies targeting Peru and the Andean Community
• CROs requiring BE/analytical outsourcing
• Regulatory teams needing DIGEMID-compliant CTD/ACTD dossiers