ValiPro – Process Validation Protocol & Report Services for Bangladesh

US FDA | EU GMP | WHO | PIC/S | DGDA & 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 Bangladesh-based manufacturers supplying to regulated global markets.

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

Who We Support in Bangladesh

ValiPro works closely with:

• Bangladesh manufacturers exporting to US, EU, UK, ASEAN, GCC, Africa & LATAM
• Companies preparing for US FDA, EU GMP, WHO & PIC/S inspections
• Firms responding to DGDA, FDA, or foreign authority validation deficiencies
• Export-oriented plants requiring globally acceptable process validation documentation
• New manufacturing units and established facilities seeking inspection-ready validation systems

Our services are designed to align with Bangladesh manufacturing practices while fully meeting international regulatory expectations.

Our Process Validation Services – Bangladesh 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
• DGDA / MOH / US FDA / EU authority query handling (post-submission or inspection)
• Gap assessment against WHO, PIC/S, EU GMP & FDA validation guidelines
• 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 batch size
• Bangladesh facility layout and GMP setup
• Target export country and regulatory pathway

Our Experience

• 870+ products supported globally
• Active projects across South Asia, Middle East, Africa, Europe & LATAM
• Validation experience covering oral solids, injectables, APIs, liquids, semi-solids, extracts, oils, and chemicals
• Hands-on regulatory exposure with US FDA, EU Authorities, WHO, PIC/S & 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)
• US FDA Process Validation Guidance
• EU GMP Guidelines & Annexes
• PIC/S GMP Requirements
• Bangladesh DGDA and importing country MOH expectations

Industries We Serve in Bangladesh

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

Why Bangladesh Companies Choose ValiPro

• Authority-ready, inspection-focused validation documentation
• Validation formats accepted across multiple export markets
• Strong expertise in inspection response and regulatory query handling
• Reduced observations, delays, and rework
• Confidential, professional, and deadline-driven execution
• Deep understanding of Bangladesh GMP operations and export requirements

How to Get Started

To initiate a validation project for your Bangladesh facility, 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 prepare a customized scope of work and commercial proposal aligned with your regulatory objectives.