ValiPro – Global Process Validation Protocol & Report Services for South Africa

US FDA | EU GMP | WHO | PIC/S | South Africa SAHPRA 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 South African market.

Since 2008, ValiPro has been supporting Indian manufacturers, South Africa–based pharmaceutical companies, importers, distributors, and Marketing Authorization Holders (MAHs) with regulatory-compliant, authority-acceptable validation documentation, ensuring smooth South African Health Products Regulatory Authority (SAHPRA) approvals, reduced regulatory observations, and faster market access.

Who We Support – South Africa Market

ValiPro works closely with:

• South African pharmaceutical companies importing products from India
• Indian manufacturers exporting finished formulations, APIs, and intermediates to South Africa
• Marketing Authorization Holders (MAHs) submitting dossiers to SAHPRA
• Companies preparing for SAHPRA GMP inspections and compliance audits
• Firms responding to SAHPRA 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 SAHPRA, PIC/S, WHO, and international regulatory expectations.

Our Process Validation Services

We provide complete lifecycle support for process validation documentation required for SAHPRA submissions, GMP compliance, and post-approval commitments, including:

• Preparation of Process Validation Protocols
• Preparation of Process Validation Reports
• Independent technical review of existing validation documents
• SAHPRA / MOH / US FDA / EU authority query handling (post-submission)
• Gap assessment against SAHPRA GMP, PIC/S, WHO, EU GMP, 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
• South Africa–specific regulatory and GMP expectations

Our Experience Supporting South Africa & Global Markets

• 870+ products supported globally
• Active projects across Africa, Asia, Middle East, Europe & LATAM
• Experience covering oral solids, injectables, APIs, semi-solids, liquids, extracts, oils, and chemicals
• Hands-on regulatory exposure with SAHPRA, 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, Q9, Q10
• WHO Technical Report Series (TRS)
• US FDA Process Validation Guidance
• EU GMP Guidelines & Annexes
• PIC/S GMP Requirements
• SAHPRA GMP and validation guidelines

Industries We Serve – South Africa Submissions

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

Why South Africa–Focused Companies Choose ValiPro

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

How to Get Started – South Africa Projects

To initiate a South Africa–focused process validation project, simply share:

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

Our team will provide a customized technical scope and commercial proposal, fully aligned with SAHPRA requirements.