🇨🇬 Bioavailability & Bioequivalence (BA/BE) Studies Services for the Republic of Congo
Compliance for both the Republic of the Congo (RoC) and the Democratic Republic of the Congo (DRC) requires a robust GHS-compliant SDS, primarily in French, to support strict import and registration procedures.
1. Format and System (GHS Foundation)
Mandatory Format: The SDS must strictly adhere to the internationally recognized 16-Section GHS Format. This is the standard expected by customs, environment, and commerce authorities in both nations for technical assessment and risk evaluation.
Compliance with Conventions: Both countries are parties to major international chemical conventions (Basel, Rotterdam, Stockholm). The SDS must clearly confirm that the product complies with any international restrictions or prior informed consent procedures, documented in Section 15 (Regulatory Information).
Best Practice Classification: The SDS must include accurate GHS classification (pictograms, signal words, hazard/precautionary statements) in Section 2.
2. Language Requirement (French Mandate)
Official Language: The official language for government and business in both the RoC and the DRC is French (Français).
SDS Language: The SDS must be provided in French to meet regulatory requirements, facilitate customs clearance, and ensure worker safety training is compliant with local labor laws.
Recommendation: English may be provided as a suDPML/CEMAC-Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt. Ltd., provides end-to-end Bioavailability/Bioequivalence (BA/BE) Study Services and Comparative Dissolution Profiling (CDP) tailored to the regulatory requirements of the Republic of the Congo’s DPML (Direction de la Pharmacie et du Médicament et des Laboratoires).
All studies comply with CEMAC/ECCAS harmonized frameworks, WHO TRS, ICH, GCP, and GLP, enabling pharmaceutical companies to achieve regulatory approvals in Congo and throughout Central Africa.
đź’Š Core Services for Congo (DPML / CEMAC) Regulatory Submissions
Clinical BA/BE Studies (Human)
Study Designs: Single-dose & multiple-dose, crossover & parallel designs consistent with WHO/ICH norms.
Volunteer Selection: Healthy volunteers recruited under strict GCP-compliant procedures.
Ethics Approval: Required from Comité National d’Éthique pour la Recherche en Santé (CNERS) or a DPML-recognized IRB.
Protocol Development: Aligned with WHO BA/BE guidelines, ICH E6 (R2), and DPML/CEMAC submission expectations.
Comparative Dissolution Profiling (CDP)
Regulatory Requirement: Essential for generic drug approvals and formulation variations in Congo.
Dissolution Media: Biorelevant & pharmacopoeial media following WHO/ICH recommendations.
Similarity Assessment: f2 similarity factor, model-dependent and model-independent analyses.
Reporting: Delivered in formats compatible with DPML and CEMAC CTD dossier structures.
IVIVC & Biowaiver Support
BCS Biowaiver: Prepared according to WHO, ICH Q6A, and African regulatory harmonization guidelines.
IVIVC Models: Level A, B, and C biopharmaceutic correlations.
Predictive Analysis: In vitro–in vivo performance assessment to support regulatory decisions.
Analytical Method Development & Validation
Platforms: LC-MS/MS & HPLC-UV analytical systems.
Validation: Conducted according to ICH M10 and WHO-endorsed validation guidelines.
Stability Testing: Stability-indicating methods for APIs and finished pharmaceutical products.
Pharmacokinetic (PK) & Bioequivalence Statistics
PK Modelling: Non-compartmental analysis (NCA).
BE Statistical Evaluation: ANOVA, CI-based analysis for Cmax/AUC per WHO/ICH standards.
Sample Size Calculations: Based on variability and BE acceptance ranges.
📑 Congo (DPML)–Ready Regulatory Documentation
We prepare complete documentation sets that comply with DPML, CEMAC, and WHO CTD formats.
Includes:
Clinical Study Protocol
Informed Consent Forms (French & English if required)
Investigator’s Brochure
Clinical Study Report (CSR) in WHO/CTD-compatible format
Bioanalytical Method Validation Report
Comparative Dissolution Profile Report
CTD/ACTD Modules tailored for CEMAC & DPML
Supplementary DPML forms for generic applications
✨ Why Choose BioEquiGlobal for Congo?
Regulatory Expertise: Familiar with DPML rules and Central African (CEMAC/ECCAS) harmonized guidelines.
Quality & Compliance: All studies executed under GCP, GLP, ICH, and WHO frameworks.
Modern Infrastructure: Access to accredited clinical units and validated analytical laboratories.
Regional Reach: Capability to support submissions across Congo, DRC, Cameroon, Gabon, Chad, CAR, and other African markets.
Global Support: Dossier preparation for EU, US FDA, GCC, India, and additional regulatory regions.
🗺️ Our BA/BE Workflow for Congo
1. Feasibility & Regulatory Assessment
Evaluation of reference product, dossier pathway, and CEMAC/DPML requirements.
2. Protocol Development & Ethics Approval
Development of WHO/ICH-aligned protocols and securing CNERS/IRB approval.
3. Analytical Method Development
ICH M10–based LC-MS/MS method development and validation.
4. Clinical Study Execution
Recruitment, dosing, sampling, and safety monitoring under strict GCP compliance.
5. Bioanalysis, PK & BE Evaluation
Bioanalysis, PK modelling, statistical BE assessment.
6. Documentation & Dossier Preparation
CSR compilation, CDP reporting, and CTD assembly for DPML submission.
Who We Support in Congo & Central Africa
Pharmaceutical manufacturers seeking DPML/CEMAC product approval.
Companies submitting to multiple Central African markets.
CROs requiring analytical or clinical BA/BE support.
Regulatory teams preparing CTD/ACTD dossiers for Congo and regional agencies.pplementary technical document for international trade partners.
3. Regulatory and Documentation Focus
🇨🇩 Democratic Republic of the Congo (DRC)
Import License (LIB): Hazardous chemicals require an Import License (Licence d'Importation des Biens - LIB) obtained from a Congolese commercial bank. The SDS is essential supporting documentation for this process.
Pre-Shipment Inspection: Imports over $2,500 require a pre-shipment inspection by agencies like Bureau Veritas (BIVAC) to obtain a Certificate of Validation (Attestation de VĂ©rification - AV). The SDS data supports this inspection process.
Environmental Protection Act (EPA): DRC law specifies heavy penalties for operators who import, use, or discharge toxic chemicals in violation of the EPA, underscoring the critical need for an accurate SDS.
🇨🇬 Republic of the Congo (RoC)
Similar to the DRC, the RoC requires permits for the import and use of hazardous chemicals, with the SDS serving as the primary source of hazard information for all government agencies involved in the approval process.