ValiPro – Global Process Validation Protocol & Report Services for Seychelles

US FDA | EU GMP | WHO | PIC/S | Seychelles MOH / 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 Seychelles and the wider Indian Ocean & African region.

Since 2008, ValiPro has been supporting Indian manufacturers, Seychelles-based importers, distributors, and Marketing Authorization Holders (MAHs) with regulatory-compliant, authority-acceptable validation documentation, ensuring smooth Seychelles Ministry of Health (MOH) / Seychelles Food and Drug Administration (SFDA) approvals, reduced regulatory observations, and faster market access.

Who We Support – Seychelles Market

ValiPro works closely with:

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

Our services are designed to align Indian GMP practices with Seychelles MOH / SFDA, WHO, and international regulatory expectations.

Our Process Validation Services

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

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

Our Experience Supporting Seychelles & 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 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
• Seychelles MOH / SFDA GMP and validation expectations

Industries We Serve – Seychelles 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 Seychelles-Focused Companies Choose ValiPro

• SFDA-aligned, authority-ready validation documentation
• Validation formats accepted across Seychelles, Indian Ocean region, WHO & PIC/S markets
• Strong expertise in WHO-aligned GMP and small-market regulatory submissions
• Reduced MOH / SFDA observations, approval delays, and rework
• Confidential, professional, and deadline-driven execution
• Deep understanding of Indian manufacturing operations supplying island and African markets

How to Get Started – Seychelles Projects

To initiate a Seychelles-focused process validation project, simply share:

• Product and manufacturing process details
• Dosage form and batch size
• Indian manufacturing site information
• Target registration or inspection timeline
• Existing validation data (if available)

Our team will provide a customized technical scope and commercial proposal, fully aligned with Seychelles MOH / SFDA and WHO requirements.