ValiPro – Process Validation Protocol & Report Services for Cambodia

US FDA | EU GMP | WHO | PIC/S | Cambodia MOH & Global Authority Compliant

ValiPro, a specialized scientific arm of Zoesoe Exports Pvt Ltd, provides end-to-end Process Validation Protocol and Process Validation Report preparation, review, and regulatory support services for Cambodia-based manufacturers supplying to regulated international markets.

Since 2008, ValiPro has been supporting Cambodian pharmaceutical, API, cosmetic, herbal, food, and chemical manufacturers with regulatory-compliant, authority-acceptable validation documentation, helping ensure smooth approvals, reduced inspection observations, and faster access to export markets.

Who We Support in Cambodia

ValiPro works closely with:

• Cambodian manufacturers exporting to ASEAN, US, EU, UK, GCC, Africa & LATAM
• Companies preparing for Ministry of Health (MOH) Cambodia, WHO & importing-country GMP inspections
• Firms responding to validation deficiencies, inspection observations, and regulatory queries
• Export-oriented facilities requiring globally acceptable process validation documentation
• New plants and established sites upgrading to WHO / PIC/S GMP standards

Our services are structured to meet Cambodia manufacturing realities while fully aligning with international regulatory expectations.

Our Process Validation Services – Cambodia Focus

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

• Preparation of Process Validation Protocols (PVPs)
• Preparation of Process Validation Reports (PVRs)
• Independent technical review of existing validation documents
• MOH Cambodia / WHO / importing-country authority query handling
• Gap assessment against WHO TRS, PIC/S, EU GMP & FDA validation guidelines
• Supply of ready-to-use, regulator-accepted validation templates

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

• Product type and dosage form
• Manufacturing process, equipment, and batch size
• Cambodia facility layout and GMP infrastructure
• Target export market and regulatory pathway

Our Experience

• 870+ products supported globally
• Active projects across Asia, Middle East, Africa, Europe & LATAM
• Experience covering oral solids, injectables, APIs, liquids, semi-solids, herbal products, extracts, oils, and chemicals
• Hands-on regulatory exposure with US FDA, EU Authorities, WHO, PIC/S & country MOHs
• Proven success in new registrations, revalidation, variations, and renewals

Regulatory Standards Followed

Our process validation documentation is aligned with:

• ICH Q8, Q9 & Q10
• WHO Technical Report Series (TRS)
• WHO GMP & Validation Guidelines
• US FDA Process Validation Guidance
• EU GMP Guidelines & Annexes
• PIC/S GMP Requirements
• Cambodia Ministry of Health (MOH) expectations

Industries We Serve in Cambodia

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

Why Cambodia Companies Choose ValiPro

• Authority-ready, inspection-focused validation documentation
• Validation formats accepted across multiple export markets
• Strong expertise in WHO, MOH & international inspection support
• Reduced regulatory observations, delays, and rework
• Confidential, professional, and deadline-driven execution
• Practical understanding of Cambodia GMP operations and export requirements

How to Get Started

To initiate a validation project for your Cambodia facility, simply share:

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

Our technical team will provide a customized technical scope and commercial proposal aligned with Cambodia regulatory and export objectives.