🇨🇴 Bioavailability & Bioequivalence (BA/BE) Studies Services for Colombia

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

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt. Ltd., provides comprehensive Bioavailability & Bioequivalence (BA/BE) study services and Comparative Dissolution Profiling (CDP) tailored for Colombia’s INVIMA regulatory framework.

All studies follow Colombian Resolutions (especially Resolución 1124/2016), WHO TRS, ICH, GCP, and GLP — supporting pharmaceutical companies submitting generic, similar, and reference-equivalent medicines for approval in Colombia and across Latin America.

💊 Core Services for Colombia (INVIMA)

1. Clinical BA/BE Studies (Human)

(Aligned with Resolución 1124/2016 & INVIMA BA/BE norms)

• Study Designs: Single-dose, multiple-dose, crossover & parallel designs per INVIMA guidelines.

• Volunteer Selection: Healthy volunteers under strict ICH-GCP procedures.

• Ethics Approval: Required from an accredited Comité de Ética en Investigación (CEI) in Colombia.

• Clinical Protocol: Developed according to ICH E6 (R2), WHO BA/BE, and Colombian regulatory expectations.

2. Comparative Dissolution Profiling (CDP)

(Mandatory for equivalence, reformulations, and biowaiver dossiers)

• Dissolution Media: Biorelevant & pharmacopoeial media (USP/Ph.Eur.) in line with INVIMA guidelines.

• Similarity Factors: f2 similarity factor and kinetic/model-based comparisons.

• Reporting: Structured for CTD Module 3, accepted by INVIMA.

3. IVIVC & Biowaiver Support

• BCS Biowaiver: Prepared following WHO, ICH Q6A, and INVIMA criteria for biowaiver-eligible APIs.

• IVIVC Models: Level A, B, and C correlations for dissolution–PK bridging.

• Predictive Evaluation: PK-dissolution modeling supporting waiver justification.

4. Analytical Method Development & Validation

(Aligned with ICH M10 and Colombian standards)

• Platforms: LC-MS/MS & HPLC-UV.

• Validation: Selectivity, accuracy, precision, sensitivity, stability — as required by INVIMA.

• Stability Studies: Stability-indicating methods for APIs & finished products.

5. Pharmacokinetic (PK) & Bioequivalence Statistics

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

• BE Statistical Analysis: CI-based BE evaluation for AUC, Cmax according to INVIMA requirements.

• Sample Size & Power: Determined using variability & INVIMA-specified acceptance ranges.

📑 Colombia (INVIMA)–Ready Regulatory Documentation

We prepare complete documentation sets aligned with INVIMA’s CTD format, including:

• Clinical Study Protocol

• Informed Consent Forms (Spanish required for CEI review)

• Investigator’s Brochure

• Clinical Study Report (CSR) following INVIMA & ICH structure

• Bioanalytical Method Validation Report

• Comparative Dissolution Profile Report

• CTD Modules 1–5 for INVIMA submission

• Required INVIMA administrative templates (solicitudes, formularios, anexos)

✨ Why Choose BioEquiGlobal for the Colombian Market?

• Regulatory Expertise: Deep understanding of INVIMA’s BA/BE framework and Colombian Resolution 1124/2016.

• High Quality: All studies conducted under ICH-GCP, GLP, WHO, and international BA/BE best practices.

• Strong Technical Infrastructure: Access to validated analytical labs and accredited clinical research centers.

• LATAM Coverage: Support for Colombia + regional submissions (Peru, Chile, Ecuador, Mexico, Argentina, Brazil).

• End-to-End Execution: From feasibility to CTD assembly and INVIMA dossier submission.

🗺️ Our BA/BE Workflow for Colombia

1. Feasibility & Colombian Regulatory Gap Assessment

Determination of reference product requirements, biowaiver potential, and INVIMA expectations.

2. Protocol Development & Ethics Approval

Creation of an INVIMA-compliant protocol and submission to a Colombian CEI for approval.

3. Analytical Method Development & Validation

ICH M10-compliant development and validation of bioanalytical methods.

4. Clinical Study Execution

Volunteer enrolment, dosing, sampling, safety monitoring under GCP.

5. Bioanalysis, PK & BE Evaluation

Bioanalytical processing, PK modeling, BE statistical analysis.

6. Documentation & Submission to INVIMA

Compilation of CSR, CDP, and complete CTD dossier for INVIMA review.

Who We Support in Colombia & Latin America

• Generic and similar-product manufacturers targeting INVIMA approval

• Pharmaceutical companies expanding into the Andean Region

• CROs outsourcing BA/BE clinical or analytical components

• Regulatory affairs teams preparing CTD/ACTD dossiers