ValiPro – Global Process Validation Protocol & Report Services for Indonesia

US FDA | EU GMP | WHO | PIC/S | Indonesia BPOM (Badan POM) 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 Indonesia-based pharmaceutical and manufacturing companies supplying to regulated domestic and global markets.

Since 2008, ValiPro has been supporting manufacturers, MA holders, exporters, and regulatory teams with regulatory-compliant, authority-acceptable validation documentation, ensuring smooth approvals, reduced regulatory observations, and faster market access.

Who We Support in Indonesia

ValiPro works closely with:

• Indonesian pharmaceutical and API manufacturers
• Companies registered or submitting products to BPOM Indonesia
• Firms exporting to US, EU, UK, ASEAN, GCC, Africa & LATAM
• Companies preparing for BPOM, WHO, PIC/S, US FDA, or EU GMP inspections
• Businesses responding to BPOM deficiencies, inspection observations, and regulatory queries
• Local companies outsourcing manufacturing to India, ASEAN, or other PIC/S countries

Our services are designed to fully align with BPOM GMP requirements while meeting international validation expectations.

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
• BPOM / MOH / FDA / EU authority query handling (post-submission)
• Gap assessment against Indonesia 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, equipment, and batch size
• Actual manufacturing site layout and controls
• Target export and registration markets
• BPOM Indonesia and overseas authority expectations

Our Experience

• 870+ products supported globally
• Active projects across Asia, Middle East, Africa, Europe & LATAM
• Experience with oral solids, injectables, APIs, semi-solids, liquids, extracts, oils, foods, cosmetics, and chemicals
• Hands-on regulatory exposure with BPOM Indonesia, US FDA, EU Authorities, WHO, PIC/S & country MOHs
• 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 Requirements
• Indonesia BPOM GMP (CPOB) expectations
• Country-specific MOH and validation requirements

Industries We Serve – Indonesia Focus

• Pharmaceuticals & APIs
• OTC and prescription medicines
• Cosmetics & personal care products
• Traditional medicine, herbal & natural extracts
• Food & nutraceutical ingredients
• Essential oils & fragrances
• Agrochemicals and industrial chemicals

Why Indonesian Companies Choose ValiPro

• BPOM-ready, authority-focused validation documentation
• Validation formats accepted across ASEAN and global markets
• Strong expertise in inspection readiness and regulatory query response
• Reduced BPOM observations and re-submission cycles
• Confidential, professional, and timeline-driven execution
• Deep understanding of ASEAN GMP realities and global regulatory alignment

How to Get Started

To initiate a validation project, simply share:

• Product and manufacturing process details
• Dosage form and batch size
• Manufacturing site location
• Target export countries
• BPOM submission or inspection timeline
• Existing validation data (if available)

Our technical team will provide a customized technical scope and commercial proposal aligned with Indonesia BPOM and global regulatory requirements.