ValiPro – Global Process Validation Protocol & Report Services for Hong Kong

US FDA | EU GMP | WHO | PIC/S | Hong Kong Department of Health (DH) 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 Hong Kong–based pharmaceutical and manufacturing companies supplying to regulated global markets.

Since 2008, ValiPro has been supporting manufacturers, exporters, brand owners, and regulatory teams with regulatory-compliant, authority-acceptable validation documentation, helping ensure smooth approvals, reduced regulatory observations, and faster market access across multiple international jurisdictions.

Who We Support in Hong Kong

ValiPro works closely with:

• Hong Kong pharmaceutical manufacturers and brand owners
• Importers and MA holders supplying products to US, EU, UK, ASEAN, GCC, China & global markets
• Companies preparing for US FDA / EU GMP / WHO / PIC/S inspections
• Firms responding to Department of Health (DH) queries, overseas authority observations, and deficiencies
• Trading companies outsourcing manufacturing to India, ASEAN, or China requiring globally acceptable validation documentation

Our services are structured to align with Hong Kong regulatory expectations while fully meeting international GMP and validation 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 documents
• Post-submission authority query handling (DH, FDA, EU, WHO, PIC/S)
• Gap assessment against Hong Kong GMP and country-specific validation requirements
• 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, equipment, and scale
• Actual manufacturing site setup (India / ASEAN / China / global)
• Target export market and registration pathway
• Hong Kong DH and overseas authority expectations

Our Experience

• 870+ products supported globally
• Active projects across Asia, Middle East, Africa, Europe & LATAM
• Experience across oral solids, injectables, APIs, semi-solids, liquids, extracts, oils, cosmetics, foods, and chemicals
• Hands-on regulatory exposure with US FDA, EU Authorities, WHO, PIC/S & country MOHs
• 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 Requirements
• Hong Kong Department of Health (Drug Office) expectations
• Country-specific MOH validation and GMP requirements

Industries We Serve – Hong Kong Focus

• Pharmaceuticals & APIs
• OTC and prescription products
• Cosmetics & personal care products
• Herbal, traditional medicine & natural extracts
• Essential oils & fragrances
• Food & nutraceutical ingredients
• Chemicals and industrial products

Why Hong Kong Companies Choose ValiPro

• Authority-ready, inspection-focused validation documentation
• Validation formats accepted across multiple export markets
• Strong expertise in inspection preparation and deficiency response
• Reduced regulatory observations and rework cycles
• Confidential, professional, and deadline-driven execution
• Deep understanding of Asian outsourcing and global supply chains

How to Get Started

To initiate a validation project, simply share:

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

Our technical team will prepare a customized technical scope and commercial proposal aligned with Hong Kong and global regulatory requirements.