ValiPro – Global Process Validation Protocol & Report Services for Rwanda

US FDA | EU GMP | WHO | PIC/S | Rwanda FDA (Rwanda FDA) 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 Rwanda and the wider East African region.

Since 2008, ValiPro has been supporting Indian manufacturers, Rwanda-based importers, distributors, NGOs, and Marketing Authorization Holders (MAHs) with regulatory-compliant, authority-acceptable validation documentation, ensuring smooth Rwanda FDA approvals, reduced regulatory observations, and faster market access.

Who We Support – Rwanda Market

ValiPro works closely with:

• Rwanda pharmaceutical importers and distributors sourcing from India
• Indian manufacturers exporting finished formulations and APIs to Rwanda
• Marketing Authorization Holders (MAHs) submitting dossiers to Rwanda FDA
• Companies preparing for Rwanda FDA GMP inspections and compliance audits
• Firms responding to Rwanda FDA validation-related deficiencies and regulatory queries
• Companies supplying public tenders, donor-funded, and NGO healthcare programs

Our services are designed to align Indian GMP practices with Rwanda FDA, WHO, and international regulatory expectations.

Our Process Validation Services

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

• Preparation of Process Validation Protocols
• Preparation of Process Validation Reports
• Independent technical review of existing validation documents
• Rwanda FDA / WHO authority query handling (post-submission)
• Gap assessment against Rwanda GMP, WHO TRS, PIC/S, and ICH 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
• Rwanda-specific and WHO-aligned regulatory requirements

Our Experience Supporting Rwanda & Global 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 Rwanda FDA, 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
• Rwanda FDA GMP and validation expectations

Industries We Serve – Rwanda 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 Rwanda-Focused Companies Choose ValiPro

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

How to Get Started – Rwanda Projects

To initiate a Rwanda-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 Rwanda FDA and WHO requirements.