ValiPro – Global Process Validation Protocol & Report Services for Iraq

Compliant with US FDA | EU | WHO | PIC/S | Iraq MoH

ValiPro, a specialized scientific arm of Zoesoe Exports Pvt Ltd, provides end-to-end Process Validation Protocol and Process Validation Report preparation and review services for Iraqi manufacturers supplying regulated regional and global markets.

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

Who We Support in Iraq

ValiPro works closely with:

• Iraqi manufacturers exporting to US, EU, UK, GCC, MENA, Africa & LATAM

• Companies preparing for US FDA, EU GMP, WHO, PIC/S inspections

• Firms responding to Iraq Ministry of Health (MoH) regulatory deficiencies and validation queries

• New startups and established manufacturing facilities requiring globally acceptable validation documentation

Our services are designed to meet Iraq GMP requirements, 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

• Post-submission regulatory query handling (Iraq MoH, FDA, EU, WHO, PIC/S)

• Gap assessments against Iraq GMP and country-specific validation guidelines

• Supply of ready-to-use, regulator-accepted validation templates

Each document is custom-developed and tailored based on:

• Product category and dosage form

• Manufacturing process design and batch size

• Iraqi facility layout and operations

• Target export market regulatory expectations

Our Experience

• 870+ products supported globally

• Active projects across Middle East, Asia, Africa, Europe & LATAM

• Experience across oral solids, injectables, APIs, semi-solids, liquids, extracts, oils & chemicals

• Hands-on regulatory exposure with US FDA, EU Authorities, WHO, PIC/S & country MoHs

• Proven success in new registrations, variations, revalidation & 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 Requirements

• Iraq Ministry of Health (MoH) expectations

Industries We Serve in Iraq

• Pharmaceuticals & APIs

• Cosmetics & Personal Care

• Herbal & Natural Products

• Essential Oils & Fragrances

• Food & Nutraceutical Ingredients

• Agrochemicals

• Industrial & Specialty Chemicals

Why Iraqi Companies Choose ValiPro

• Authority-ready, inspection-focused validation documentation

• Formats accepted across multiple regional and international markets

• Strong expertise in inspection readiness and regulatory query response

• Reduced regulatory observations, delays, and rework

• Confidential, professional, and timeline-driven execution

• Practical understanding of Iraqi manufacturing and regulatory realities

How to Get Started

To initiate a project, please share:

• Product and manufacturing process details

• Dosage form and batch size

• Target export markets

• Submission or inspection timeline

• Existing validation data (if available)

Our team will provide a custom technical scope and commercial proposal tailored to your requirements.