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