ValiPro – Global Process Validation Protocol & Report Services for Myanmar

US FDA | EU | WHO | PIC/S | Myanmar FDA (MoHS) 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 Myanmar-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 access to international markets.

Who We Support in Myanmar

ValiPro works closely with:

• Myanmar manufacturers exporting to ASEAN, US, EU, UK, GCC, Africa & LATAM
• Companies preparing for Myanmar FDA (MoHS), WHO, EU GMP & PIC/S inspections
• Firms responding to regulatory deficiencies, inspection observations, and validation queries
• New manufacturing facilities and existing plants requiring globally acceptable validation documentation
• Export-oriented manufacturers transitioning from local to international compliance

Our services are structured to meet Myanmar GMP and MoHS expectations while remaining fully aligned 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
• Myanmar FDA / WHO / EU authority query handling (post-submission & inspection support)
• Gap assessment against Myanmar-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
• Myanmar facility layout, utilities, and operational controls
• Target export market regulatory requirements

Our Experience

• 870+ products supported globally
• Active projects across ASEAN, South Asia, Middle East, Africa, Europe & LATAM
• Experience across oral solids, injectables, APIs, semi-solids, liquids, herbal extracts, oils, and chemicals
• Direct regulatory exposure with Myanmar FDA, WHO, EU Authorities & PIC/S
• 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
• Myanmar FDA (MoHS) validation expectations

Industries We Serve in Myanmar

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

Why Myanmar Companies Choose ValiPro

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

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 Myanmar FDA and global regulatory requirements.