ValiPro – Global Process Validation Protocol & Report Services for Burundi

US FDA | EU GMP | WHO | PIC/S | Burundi MOH / DPM Aligned

ValiPro is a specialized scientific arm of Zoesoe Exports Pvt Ltd, providing end-to-end Process Validation Protocol and Process Validation Report preparation, review, and regulatory support services for products supplied to the Republic of Burundi and the wider East & Central African market.

Since 2008, ValiPro has been supporting Indian manufacturers, Burundi-based importers, distributors, NGOs, and Marketing Authorization Holders (MAHs) with regulatory-compliant, authority-acceptable validation documentation, ensuring smooth Ministry of Health (MOH) / Direction de la Pharmacie et du Médicament (DPM) approvals, reduced regulatory observations, and faster market access.

Who We Support – Burundi Market

ValiPro works closely with:

• Burundi pharmaceutical importers and distributors sourcing from India
• Indian manufacturers exporting finished formulations and APIs to Burundi
• Marketing Authorization Holders (MAHs) submitting dossiers to Burundi MOH / DPM
• Companies supplying public tenders, donor-funded, and NGO healthcare programs
• Firms responding to MOH / WHO validation-related deficiencies and queries
• Startups and established manufacturers requiring Africa-acceptable validation documentation

Our services are designed to align Indian GMP practices with Burundi MOH, WHO, and regional African regulatory expectations.

Our Process Validation Services

We provide complete lifecycle support for process validation documentation required for Burundi registrations, renewals, and GMP compliance, including:

• Preparation of Process Validation Protocols
• Preparation of Process Validation Reports
• Independent technical review of existing validation documents
• Burundi MOH / WHO authority query handling (post-submission)
• Gap assessment against WHO TRS, PIC/S, and African GMP guidelines
• Supply of ready-to-use, regulator-accepted validation templates

Each document is custom-developed (not generic) and tailored based on:

• Product category and dosage form
• Manufacturing process, controls, and batch size
• Indian manufacturing facility setup
• Burundi-specific and WHO-aligned regulatory requirements

Our Experience Supporting Burundi & African Markets

• 870+ products supported globally
• Active projects across Africa, Asia, Middle East, Europe & LATAM
• Experience covering oral solids, injectables, APIs, semi-solids, liquids, extracts, oils, and chemicals
• Hands-on regulatory exposure with African MOHs, WHO, PIC/S, US FDA & EU Authorities
• Proven success in new registrations, variations, revalidation, and renewals

Regulatory Standards Followed

ValiPro’s process validation documentation aligns with:

• ICH Q8, Q9, Q10
• WHO Technical Report Series (TRS)
• US FDA Process Validation Guidance
• EU GMP Guidelines & Annexes
• PIC/S GMP Requirements
• Burundi Ministry of Health (MOH) / DPM expectations

Industries We Serve – Burundi Submissions

• Pharmaceuticals & Finished Dosage Forms
• Active Pharmaceutical Ingredients (APIs)
• Injectables & Sterile Products
• Cosmetics & Personal Care Products
• Herbal & Natural Products
• Essential Oils & Extracts
• Food & Nutraceutical Ingredients
• Industrial & Specialty Chemicals

Why Burundi-Focused Companies Choose ValiPro

• MOH-aligned, authority-ready validation documentation
• Validation formats accepted across Burundi, East & Central Africa, WHO & PIC/S markets
• Strong expertise in WHO-aligned GMP, donor programs, and tender submissions
• Reduced MOH observations, approval delays, and rework
• Confidential, professional, and deadline-driven execution
• Deep understanding of Indian manufacturing operations supplying Africa

How to Get Started – Burundi Projects

To initiate a Burundi-focused process validation project, simply share:

• Product and manufacturing process details
• Dosage form and batch size
• Indian manufacturing site information
• Target registration, tender, or inspection timeline
• Existing validation data (if available)

Our team will provide a customized technical scope and commercial proposal, fully aligned with Burundi MOH / DPM and WHO requirements.