ValiPro – Process Validation Protocol & Report Services for Bhutan

US FDA | EU GMP | WHO | PIC/S | Bhutan DRA & Global MOH 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 Bhutan-based manufacturers supplying to regulated international markets.

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

Who We Support in Bhutan

ValiPro works closely with:

• Bhutan manufacturers exporting to India, ASEAN, GCC, Africa, EU & other regulated markets
• Companies preparing for Drug Regulatory Authority (DRA) Bhutan, WHO & importing country inspections
• Firms responding to DRA Bhutan validation deficiencies and regulatory queries
• Export-oriented facilities requiring globally acceptable process validation documentation
• New manufacturing units and existing plants upgrading to WHO / PIC/S GMP standards

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

Our Process Validation Services – Bhutan 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
• DRA Bhutan / MOH / importing country authority query handling
• Gap assessment against WHO TRS, PIC/S & international GMP 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
• Bhutan facility layout and GMP infrastructure
• Target export country requirements

Our Experience

• 870+ products supported globally
• Active projects across South Asia, Middle East, Africa, Europe & LATAM
• Experience covering oral solids, liquids, semi-solids, APIs, herbal products, extracts, oils, and chemicals
• Hands-on regulatory exposure with WHO, PIC/S, US FDA, EU authorities & 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
• Drug Regulatory Authority (DRA), Bhutan expectations

Industries We Serve in Bhutan

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

Why Bhutan Companies Choose ValiPro

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

How to Get Started

To initiate a validation project for your Bhutan 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 Bhutan regulatory and export requirements.