ValiPro – Global Process Validation Protocol & Report Services for Malaysia

US FDA | EU | WHO | PIC/S | Malaysia NPRA (MOH) Compliant

ValiPro is a specialized scientific arm of Zoesoe Exports Pvt Ltd, providing end-to-end Process Validation Protocol and Process Validation Report Preparation & Review Services for Malaysia-based manufacturers supplying to regulated global markets.

Since 2008, ValiPro has been supporting pharmaceutical, API, cosmetic, herbal, food, and chemical manufacturers with regulatory-compliant, authority-acceptable process validation documentation, enabling smooth approvals, reduced inspection observations, and faster international market access.

Who We Support in Malaysia

ValiPro works closely with:

• Malaysian manufacturers exporting to US, EU, UK, ASEAN, GCC, Africa & LATAM
• Companies preparing for NPRA (MOH), US FDA, EU GMP, WHO & PIC/S inspections
• Firms responding to regulatory deficiencies, inspection observations, and validation queries
• New facilities and established plants requiring globally acceptable validation documentation
• Export-oriented manufacturers targeting regulated and semi-regulated markets

Our services are structured to meet Malaysia GMP and NPRA expectations while fully aligning with international regulatory standards.

Our Process Validation Services

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

• Preparation of Process Validation Protocols
• Preparation of Process Validation Reports
• Independent technical review of existing validation documentation
• NPRA / FDA / EU / WHO authority query handling (post-submission & inspection support)
• Gap assessment against Malaysia-specific GMP and validation guidelines
• Supply of ready-to-use, regulator-accepted validation templates

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

• Product category and dosage form
• Manufacturing process, equipment, and batch size
• Malaysian facility layout, utilities, and operational controls
• Target export market regulatory requirements

Our Experience

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

Regulatory Standards Followed

Our 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 & Validation Requirements
• Malaysia NPRA (MOH) validation expectations

Industries We Serve in Malaysia

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

Why Malaysian Companies Choose ValiPro

• Authority-ready, inspection-focused documentation
• Validation formats accepted across multiple export markets
• Strong expertise in NPRA inspections and regulatory query response
• Reduced regulatory observations and rework
• Confidential, professional, and deadline-driven execution
• Deep understanding of ASEAN manufacturing and export environments

How to Get Started

To initiate a validation project, simply share:

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

Our technical team will provide a customized technical scope and commercial proposal aligned with Malaysia NPRA and global regulatory requirements.