ValiPro – Global Process Validation Protocol & Report Services for Taiwan

US FDA | EU GMP | WHO | PIC/S | Taiwan FDA (TFDA) 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, and regulatory support services for products supplied to the Taiwan market.

Since 2008, ValiPro has been supporting Indian manufacturers, Taiwan-based pharmaceutical companies, importers, and Marketing Authorization Holders (MAHs) with regulatory-compliant, authority-acceptable validation documentation, ensuring smooth Taiwan FDA (TFDA) approvals, reduced regulatory observations, and faster market access.

Who We Support – Taiwan Market

ValiPro works closely with:

• Taiwan pharmaceutical companies importing products from India
• Indian manufacturers exporting finished formulations, APIs, and intermediates to Taiwan
• Marketing Authorization Holders (MAHs) submitting dossiers to Taiwan FDA (TFDA)
• Companies preparing for TFDA GMP inspections and compliance audits
• Firms responding to TFDA validation-related deficiencies and regulatory queries
• Startups and established manufacturers requiring globally acceptable validation documentation

Our services are designed to bridge Indian GMP practices with Taiwan FDA and international regulatory expectations.

Our Process Validation Services

We provide complete lifecycle support for process validation documentation required for TFDA submissions and GMP compliance, including:

• Preparation of Process Validation Protocols
• Preparation of Process Validation Reports
• Independent technical review of existing validation documents
• TFDA / MOH / US FDA / EU authority query handling (post-submission)
• Gap assessment against Taiwan GMP, PIC/S, WHO, and ICH 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, controls, and batch size
• Indian manufacturing facility setup
• Taiwan-specific regulatory and GMP requirements

Our Experience Supporting Taiwan & Global Markets

• 870+ products supported globally
• Active projects across Asia, Middle East, Africa, Europe & LATAM
• Experience covering oral solids, injectables, APIs, semi-solids, liquids, extracts, oils, and chemicals
• Hands-on regulatory exposure with Taiwan FDA (TFDA), US FDA, EU Authorities, WHO, PIC/S & country MOHs
• Proven success in new registrations, variations, revalidation, and renewals

Regulatory Standards Followed

ValiPro’s process validation documentation aligns with:

• ICH Q8 (Pharmaceutical Development)
• ICH Q9 (Quality Risk Management)
• ICH Q10 (Pharmaceutical Quality System)
• WHO Technical Report Series (TRS)
• US FDA Process Validation Guidance
• EU GMP Guidelines & Annexes
• PIC/S GMP Requirements
• Taiwan FDA (TFDA) GMP and validation expectations

Industries We Serve – Taiwan Submissions

• Pharmaceuticals & Finished Dosage Forms
• Active Pharmaceutical Ingredients (APIs)
• Injectables & Sterile Products
• Cosmetics & Personal Care Products
• Herbal, Traditional & Natural Products
• Essential Oils & Extracts
• Food & Nutraceutical Ingredients
• Industrial & Specialty Chemicals

Why Taiwan-Focused Companies Choose ValiPro

• TFDA-aligned, authority-ready validation documentation
• Validation formats accepted across Taiwan, US, EU, WHO & PIC/S markets
• Strong expertise in inspection readiness and regulatory query handling
• Reduced TFDA observations, approval delays, and rework
• Confidential, professional, and deadline-driven execution
• Deep understanding of Indian manufacturing operations supplying Taiwan

How to Get Started – Taiwan Projects

To initiate a Taiwan-focused process validation project, simply share:

• Product and manufacturing process details
• Dosage form and batch size
• Indian manufacturing site information
• Target submission or inspection timeline
• Existing validation data (if available)

Our team will provide a customized technical scope and commercial proposal, fully aligned with Taiwan FDA (TFDA) requirements.