ValiPro – Global Process Validation Protocol & Report Services for Guinea

US FDA | EU | WHO | PIC/S | Guinea MoH / DNPM Compliant

ValiPro is a specialized scientific arm of Zoesoe Exports Pvt Ltd, providing end-to-end Process Validation Protocol and Process Validation Report Preparation & Review Services for Guinea-based manufacturers supplying to regional and international markets.

Since 2008, ValiPro has been supporting pharmaceutical, API, cosmetic, herbal, food, and chemical manufacturers with regulatory-compliant, authority-acceptable process validation documentation, helping ensure smoother approvals, reduced inspection observations, and faster market access across Africa and global export destinations.

Who We Support in Guinea

ValiPro works closely with:

• Manufacturers in Guinea exporting to ECOWAS, West Africa, EU, GCC & international markets
• Companies preparing for Guinea MoH / DNPM, WHO GMP & PIC/S-aligned inspections
• Firms responding to regulatory deficiencies, inspection observations, and validation queries
• New manufacturing facilities and existing plants requiring globally acceptable validation documentation
• Import-substitution and export-oriented manufacturers upgrading to international GMP standards

Our services are structured to meet Guinea GMP and Ministry of Health expectations while fully aligning with international regulatory standards.

Our Process Validation Services

We provide complete lifecycle support for process validation documentation, including:

• Preparation of Process Validation Protocols
• Preparation of Process Validation Reports
• Independent technical review of existing validation documentation
• MoH / DNPM / WHO authority query handling (post-submission & inspection support)
• Gap assessment against Guinea-specific GMP and validation requirements
• Supply of ready-to-use, regulator-accepted validation templates

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

• Product category and dosage form
• Manufacturing process, equipment, and batch size
• Guinea facility layout, utilities, and operational controls
• Target export market regulatory requirements

Our Experience

• 870+ products supported globally
• Active projects across West Africa, Central Africa, Middle East, Asia, Europe & LATAM
• Experience across oral solids, injectables, APIs, semi-solids, liquids, herbal extracts, oils, and chemicals
• Direct regulatory exposure with WHO, PIC/S-aligned inspections, and African MoHs
• Proven success in new registrations, variations, revalidation, and renewals

Regulatory Standards Followed

Our 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 & Validation Requirements
• Guinea Ministry of Health / DNPM expectations

Industries We Serve in Guinea

• Pharmaceutical Finished Dosage Forms
• Active Pharmaceutical Ingredients (APIs)
• Cosmetics & Personal Care Products
• Herbal & Traditional Medicines
• Food & Nutraceutical Ingredients
• Industrial & Specialty Chemicals

Why Companies in Guinea Choose ValiPro

• Authority-ready, inspection-focused documentation
• Validation formats accepted across multiple African and international markets
• Strong expertise in WHO GMP and African regulatory inspections
• Reduced regulatory observations and rework
• Confidential, professional, and deadline-driven execution
• Deep understanding of African manufacturing and export environments

How to Get Started

To initiate a validation project, simply share:

• Product and process details
• Dosage form and batch size
• Target export countries
• Submission or inspection timeline
• Existing validation data (if available)

Our technical team will provide a customized technical scope and commercial proposal aligned with Guinea MoH / DNPM and international regulatory requirements.