ValiPro – Global Process Validation Protocol & Report Services for Brazil
US FDA | EU GMP | WHO | PIC/S | ANVISA (Brazil) 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 Brazilian market.
Since 2008, ValiPro has been supporting Indian manufacturers, Brazil-based pharmaceutical companies, importers, distributors, and Marketing Authorization Holders (MAHs) with regulatory-compliant, authority-acceptable validation documentation, ensuring smooth ANVISA approvals, reduced regulatory observations, and faster market access in Brazil and Latin America.
Who We Support – Brazil Market
ValiPro works closely with:
• Brazilian pharmaceutical companies importing products from India
• Indian manufacturers exporting finished formulations, APIs, and intermediates to Brazil
• Marketing Authorization Holders (MAHs) submitting dossiers to ANVISA
• Companies preparing for ANVISA GMP inspections and certification (CBPF)
• Firms responding to ANVISA validation-related deficiencies and regulatory queries
• Startups and established manufacturers requiring LATAM-acceptable validation documentation
Our services are designed to bridge Indian GMP practices with ANVISA, WHO, PIC/S, and international regulatory expectations.
Our Process Validation Services
We provide complete lifecycle support for process validation documentation required for ANVISA submissions, GMP certification, and post-approval commitments, including:
• Preparation of Process Validation Protocols
• Preparation of Process Validation Reports
• Independent technical review of existing validation documents
• ANVISA / US FDA / EU authority query handling (post-submission)
• Gap assessment against ANVISA RDCs, PIC/S, WHO TRS, 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
• Brazil-specific regulatory and GMP requirements (ANVISA RDCs)
Our Experience Supporting Brazil & Global Markets
• 870+ products supported globally
• Active projects across Latin America, Africa, Asia, Middle East & Europe
• Experience covering oral solids, injectables, APIs, semi-solids, liquids, extracts, oils, and chemicals
• Hands-on regulatory exposure with ANVISA, US FDA, EU Authorities, WHO, PIC/S & country MOHs
• Proven success in new registrations, variations, revalidation, renewals, and CBPF-related activities
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
• ANVISA RDC GMP and validation regulations
Industries We Serve – Brazil Submissions
• Pharmaceuticals & Finished Dosage Forms
• Active Pharmaceutical Ingredients (APIs)
• Injectables & Sterile Products
• Cosmetics & Personal Care Products
• Herbal & Natural Products
• Essential Oils & Extracts
• Food & Nutraceutical Ingredients
• Industrial & Specialty Chemicals
Why Brazil-Focused Companies Choose ValiPro
• ANVISA-aligned, authority-ready validation documentation
• Validation formats accepted across Brazil, LATAM, US, EU, WHO & PIC/S markets
• Strong expertise in ANVISA GMP inspections, CBPF, and regulatory query handling
• Reduced ANVISA observations, approval delays, and rework
• Confidential, professional, and deadline-driven execution
• Deep understanding of Indian manufacturing operations supplying Brazil
How to Get Started – Brazil Projects
To initiate a Brazil-focused process validation project, simply share:
• Product and manufacturing process details
• Dosage form and batch size
• Indian manufacturing site information
• Target ANVISA submission, CBPF, or inspection timeline
• Existing validation data (if available)
Our team will provide a customized technical scope and commercial proposal, fully aligned with ANVISA requirements.