ValiPro – Global Process Validation Protocol & Report Services for Colombia

US FDA | EU GMP | WHO | PIC/S | INVIMA (Colombia) 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 Colombian market.

Since 2008, ValiPro has been supporting Indian manufacturers, Colombia-based pharmaceutical companies, importers, distributors, and Marketing Authorization Holders (MAHs) with regulatory-compliant, authority-acceptable validation documentation, ensuring smooth INVIMA approvals, reduced regulatory observations, and faster market access in Colombia and the Andean/LATAM region.

Who We Support – Colombia Market

ValiPro works closely with:

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

Our Process Validation Services

We provide complete lifecycle support for process validation documentation required for INVIMA 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
• INVIMA / US FDA / EU authority query handling (post-submission)
• Gap assessment against INVIMA regulations, 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
• Colombia-specific regulatory and GMP requirements

Our Experience Supporting Colombia & 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 INVIMA, 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
• INVIMA GMP and validation regulations

Industries We Serve – Colombia 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 Colombia-Focused Companies Choose ValiPro

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

How to Get Started – Colombia Projects

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

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

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