ValiPro – Global Process Validation Protocol & Report Services for Comoros

US FDA | EU GMP | WHO | PIC/S | Comoros 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 the Union of the Comoros and the wider East African / Indian Ocean region.

Since 2008, ValiPro has been supporting Indian manufacturers, Comoros-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 – Comoros Market

ValiPro works closely with:

• Comoros pharmaceutical importers and distributors sourcing from India
• Indian manufacturers exporting finished formulations and APIs to Comoros
• Marketing Authorization Holders (MAHs) submitting dossiers to Comoros MOH
• 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 Comoros MOH, WHO, and regional African regulatory expectations.

Our Process Validation Services

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

• Preparation of Process Validation Protocols
• Preparation of Process Validation Reports
• Independent technical review of existing validation documents
• Comoros 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
• Comoros-specific and WHO-aligned regulatory requirements

Our Experience Supporting Comoros & 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
• Comoros Ministry of Health (MOH) expectations

Industries We Serve – Comoros 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 Comoros-Focused Companies Choose ValiPro

• MOH-aligned, authority-ready validation documentation
• Validation formats accepted across Comoros, East Africa, WHO & PIC/S markets
• Strong expertise in WHO-aligned GMP and donor-funded supply programs
• 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 – Comoros Projects

To initiate a Comoros-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 Comoros MOH and WHO requirements.