🇨🇳 ValiPro: NMPA (China) GMP Validation and CMC Dossier Services For Asia

Regulatory-Compliant | Authority-Ready | Asia-Focused

ValiPro is a specialized scientific arm of Zoesoe Exports Pvt Ltd, delivering end-to-end Process Validation Protocol and Report Preparation & Review Services for pharmaceutical, cosmetic, herbal, food, and chemical manufacturers targeting Asian markets.

Since 2008, ValiPro has been supporting manufacturers across Asia with regulatory-compliant, authority-acceptable validation documentation, helping companies achieve faster approvals and smooth regulatory submissions with minimal queries.

What We Do

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
• MOH / regulatory query handling related to validation (post-submission)
• Gap assessment against country-specific GMP and validation guidelines
• Supply of ready-to-use validation templates

All documentation is customized based on product type, manufacturing process, dosage form, and country-specific regulatory expectations in Asian markets.

Our Experience

• 870+ products supported globally
• Strong regulatory experience across Asia, Middle East, Africa, Europe & LATAM
• Experience across multiple dosage forms, APIs, and industrial processes
• Regulatory exposure with US FDA, EU, WHO, PIC/S and multiple Asian MOHs
• Proven support for new submissions, variations, renewals, and tech transfers

Asian Regulatory Standards Followed

Our validation documentation aligns with internationally accepted guidelines and Asian regulatory expectations, including:

• ICH Q8 – Pharmaceutical Development
• ICH Q9 – Quality Risk Management
• ICH Q10 – Pharmaceutical Quality System
• WHO TRS Process Validation Guidelines
• US FDA Process Validation Guidance
• EU GMP & PIC/S Requirements
• ASEAN GMP & country-specific MOH requirements

Industries We Serve in Asia

• Pharmaceutical Finished Dosage Products (FDP)
• Active Pharmaceutical Ingredients (APIs)
• Cosmetics & Personal Care Products
• Herbal, Ayurveda & Natural Extract Products
• Essential Oils & Fragrance Products
• Food Ingredients & Nutraceuticals
• Agrochemicals
• Industrial Chemicals

Why Choose ValiPro

• Regulatory-focused, non-generic validation documentation
• Templates accepted across multiple Asian regulatory markets
• Extensive experience in authority query resolution
• Support for new registrations, variations, and renewals
• Confidential, professional, and deadline-driven execution