ValiPro – Global Process Validation Protocol & Report Services for Nepal

US FDA | EU | WHO | PIC/S | Nepal DDA (MoHP) 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 Nepal-based manufacturers supplying to regulated and emerging global markets.

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

Who We Support in Nepal

ValiPro works closely with:

• Nepalese manufacturers exporting to India, ASEAN, GCC, Africa, EU & other international markets
• Companies preparing for Nepal DDA, WHO GMP & PIC/S-aligned inspections
• Firms responding to regulatory deficiencies, inspection observations, and validation queries
• New manufacturing facilities and established plants requiring globally acceptable validation documentation
• Export-oriented manufacturers upgrading from local to international GMP compliance

Our services are structured to meet Nepal GMP and DDA 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
• DDA / WHO / EU authority query handling (post-submission & inspection support)
• Gap assessment against Nepal-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
• Nepal manufacturing facility design, utilities, and operations
• Target export market regulatory requirements

Our Experience

• 870+ products supported globally
• Active projects across South Asia, ASEAN, Middle East, Africa, Europe & LATAM
• Experience across oral solids, injectables, APIs, semi-solids, liquids, herbal extracts, oils, and chemicals
• Direct regulatory exposure with Nepal DDA, WHO, EU Authorities & PIC/S-aligned inspections
• 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
• Department of Drug Administration (DDA), Nepal expectations

Industries We Serve in Nepal

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

Why Nepalese Companies Choose ValiPro

• Authority-ready, inspection-focused documentation
• Validation formats accepted across multiple export markets
• Strong expertise in WHO GMP and regional regulatory inspections
• Reduced regulatory observations and rework
• Confidential, professional, and deadline-driven execution
• Deep understanding of South Asian manufacturing and export realities

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 Nepal DDA and global regulatory requirements.