ValiPro – Global Process Validation Protocol & Report Services for Iran

Compliant with US FDA | EU | WHO | PIC/S | Iran MoH / IFDA

ValiPro, a specialized scientific arm of Zoesoe Exports Pvt Ltd, provides comprehensive Process Validation Protocol and Process Validation Report preparation and review services for Iranian manufacturers supplying regulated global markets.

Since 2008, ValiPro has supported pharmaceutical, API, cosmetic, herbal, food, and chemical manufacturers with authority-acceptable, regulatory-compliant validation documentation, helping ensure successful approvals, reduced regulatory observations, and faster access to international markets.

Who We Support in Iran

ValiPro works closely with:

• Iranian manufacturers exporting to US, EU, UK, CIS, ASEAN, GCC, Africa & LATAM

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

• Firms responding to IFDA / MoH regulatory deficiencies and validation queries

• Startups and established facilities requiring globally accepted validation documentation

Our services are designed to comply with Iran GMP and IFDA 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 documents

• Post-submission authority query handling (IFDA, FDA, EU, WHO, PIC/S)

• Gap assessments against Iran GMP and country-specific 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 design and scale

• Iranian facility configuration

• 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 & IFDA

• 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

• Iran Ministry of Health (MoH) / IFDA expectations

Industries We Serve in Iran

• Pharmaceuticals & APIs

• Cosmetics & Personal Care

• Herbal, Traditional & Natural Products

• Essential Oils & Fragrances

• Food & Nutraceutical Ingredients

• Agrochemicals

• Industrial & Specialty Chemicals

Why Iranian Companies Choose ValiPro

• Authority-ready, inspection-focused validation documentation

• Formats accepted across multiple international markets

• Strong expertise in inspection readiness and regulatory query response

• Reduced regulatory observations and rework

• Confidential, professional, and timeline-driven execution

• Practical understanding of Iranian manufacturing operations

How to Get Started

To initiate a project, please share:

• Product and manufacturing process details

• Dosage form and batch size

• Target export countries

• Submission or inspection timeline

• Existing validation data (if available)

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