ValiPro – Global Process Validation Protocol & Report Services for Guinea
US FDA | EU GMP | WHO | PIC/S | Guinea MOH / DNPM 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 Guinea and the wider West African region.
Since 2008, ValiPro has been supporting Indian manufacturers, Guinea-based importers, distributors, NGOs, and Marketing Authorization Holders (MAHs) with regulatory-compliant, authority-acceptable validation documentation, ensuring smooth Ministry of Health (MOH) / Direction Nationale de la Pharmacie et du Médicament (DNPM) approvals, reduced regulatory observations, and faster market access.
Who We Support – Guinea Market
ValiPro works closely with:
• Guinea pharmaceutical importers and distributors sourcing from India
• Indian manufacturers exporting finished formulations and APIs to Guinea
• Marketing Authorization Holders (MAHs) submitting dossiers to Guinea MOH / DNPM
• 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 West Africa–acceptable validation documentation
Our services are designed to align Indian GMP practices with Guinea MOH, WHO, and regional West African regulatory expectations.
Our Process Validation Services
We provide complete lifecycle support for process validation documentation required for Guinea registrations, renewals, and GMP compliance, including:
• Preparation of Process Validation Protocols
• Preparation of Process Validation Reports
• Independent technical review of existing validation documents
• Guinea MOH / DNPM / 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
• Guinea-specific and WHO-aligned regulatory requirements
Our Experience Supporting Guinea & 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
• Guinea Ministry of Health (MOH) / DNPM expectations
Industries We Serve – Guinea 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 Guinea-Focused Companies Choose ValiPro
• MOH-aligned, authority-ready validation documentation
• Validation formats accepted across Guinea, West Africa, WHO & PIC/S markets
• Strong expertise in WHO-aligned GMP and donor / tender-based 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 – Guinea Projects
To initiate a Guinea-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 Guinea MOH / DNPM and WHO requirements.