🇵🇭 ValiPro: Global Process Validation Protocols & Reports for Philippine Exporters

Achieve Swift Global Market Access with US FDA, EU, WHO, PIC/S & Country MOH Compliant Documentation.

ValiPro, a specialized scientific arm of Zoesoe Exports Pvt Ltd, provides dedicated, end-to-end Process Validation Protocol and Report preparation & review services. We are experts in helping Philippine manufacturers meet rigorous international standards for export.

Since 2008, we have supported manufacturers in Pharmaceuticals, APIs, Cosmetics, Herbal products, Food & Chemicals, ensuring their validation documentation is globally acceptable and fully compliant with regulatory authority expectations.

🌟 Why ValiPro for Philippine Manufacturers?

Philippine companies supplying global markets require validation documentation that is not only compliant with local FDA regulations but also stands up to the strictest international audits.

• Global Expertise, Local Relevance: We ensure full alignment with US FDA, EU GMP, WHO, and PIC/S, while understanding the realities and capabilities of your Philippine-based manufacturing facility.

• Reduced Regulatory Friction: Our authority-ready documentation minimizes observations, reduces rework, and accelerates your time-to-market.

• Focus on Key Export Markets: We specialize in documentation for companies exporting to the US, EU, UK, ASEAN, GCC, Africa, and LATAM.

🎯 Who We Support in the Philippines

We work closely with:

• Export-Focused Companies: Philippine manufacturers targeting regulated markets like the US, Europe, and the Middle East.

• Inspection Readiness: Firms preparing for US FDA / EU GMP / WHO / PIC/S inspections or audits.

• Regulatory Responses: Companies needing expert assistance in responding to regulatory deficiencies and validation queries from international authorities (e.g., US FDA Warning Letters).

• Scaling & New Plants: Established or startup plants requiring globally acceptable, first-time-right validation documentation.

🛠️ Our Process Validation Services: Complete Lifecycle Support

We manage the entire validation documentation lifecycle, ensuring seamless continuity and compliance from planning to post-submission queries.

ServiceDescriptionProtocol PreparationCustom-developed Process Validation Protocols ($PVPs$) for various products and processes.Report PreparationComprehensive Process Validation Reports ($PVRs$) that present results clearly for regulatory review.Independent Technical ReviewExpert review of your existing validation documents to identify and rectify non-compliance gaps before submission.Gap AssessmentAudit of your current validation against specific international (e.g., EU GMP Annex 15) and local (e.g., Philippines FDA) guidelines.Query HandlingDedicated technical support for handling MOH / US FDA / EU authority queries post-submission.

Custom-Developed Documents: Every document is uniquely tailored based on your product category, dosage form, manufacturing scale, Philippine facility setup, and specific target market requirements.

📈 Our Proven Experience and Scope

Our track record ensures you are partnering with a reliable, experienced global expert.

• 870+ Products Supported Globally: Across a wide range of product categories.

• Diverse Product Coverage: Oral Solids, Injectables, APIs, Semi-Solids, Liquids, Herbal Extracts, Oils, and Specialty Chemicals.

• Hands-on Regulatory Exposure: Proven success in aligning documentation with US FDA, EU Authorities, WHO, PIC/S, and country Ministry of Health (MOH) requirements.

📜 Regulatory Standards We Follow

Your documentation will be built on the foundations of the world's most accepted and stringent regulatory frameworks:

• ICH Q8 (Pharmaceutical Development), Q9 (Quality Risk Management), Q10 (Pharmaceutical Quality System)

• WHO Technical Report Series (TRS)

• US FDA Process Validation Guidance

• EU GMP Guidelines & Annexes (e.g., Annex 15)

• PIC/S Requirements

• Country-specific Ministry of Health (MOH) Expectations for your target export region.

🏭 Industries We Serve in the Philippines

Our scientific expertise spans across the major regulated industries in the Philippines:

• Pharmaceuticals & APIs (Active Pharmaceutical Ingredients)

• Cosmetics & Personal Care

• Herbal, Ayurveda & Natural Extracts

• Food & Nutraceutical Ingredients

• Essential Oils & Fragrances

• Agrochemicals & Industrial Chemicals

🤝 Get Started on Your Global Validation Project

Ready to secure your compliance and accelerate your market registration?

To receive a Technical Scope and Commercial Proposal tailored to your Philippine operations, simply share the following details:

• Product: Name and Process Details

• Dosage Form: (e.g., tablet, capsule, vial) and Batch Size

• Target Export Countries: (e.g., USA, Germany, Saudi Arabia)

• Timeline: Submission or Inspection Date

• Data: Existing validation data/master batch record (if available)