ValiPro – Global Process Validation Protocol & Report Services for India
Compliant with US FDA | EU | WHO | PIC/S | Indian MoH
ValiPro, a specialized scientific arm of Zoesoe Exports Pvt Ltd, offers comprehensive Process Validation Protocol and Process Validation Report services for Indian manufacturers supplying to regulated global markets.
Since 2008, ValiPro has been partnering with Indian pharmaceutical, API, cosmetic, herbal, food, and chemical manufacturers to deliver regulatory-compliant validation documentation, ensuring smooth approvals, reduced observations, and faster market access to countries like the US, EU, WHO, and other global regulatory authorities.
Who We Support in India
ValiPro works closely with:
Indian manufacturers exporting to US, EU, UK, ASEAN, GCC, Africa, LATAM.
Companies preparing for US FDA, EU GMP, WHO inspections or addressing inspection readiness challenges.
Firms responding to regulatory deficiencies or facing queries regarding their validation processes.
Startups and established manufacturers requiring globally accepted validation documentation.
Our services are designed to align with Indian GMP standards, while fully meeting international regulatory expectations.
Our Process Validation Services
We provide end-to-end lifecycle support for process validation documentation, including:
Preparation of Process Validation Protocols tailored for specific products and regulatory requirements.
Preparation of Process Validation Reports ready for submission to regulatory authorities.
Independent technical review of existing validation documents.
Handling regulatory queries from Indian MoH, FDA, EU, and other global authorities after submission.
Gap assessments to ensure compliance with GMP and validation guidelines of different countries.
Supply of ready-to-use, regulator-accepted templates to streamline the process.
Each document is custom-developed based on:
Product category and dosage form (oral solids, injectables, etc.)
Manufacturing process and scale (pilot scale, commercial scale, etc.)
Facility setup in India (location-specific requirements).
Target export market requirements (US, EU, etc.).
Our Experience
870+ products supported globally, including Indian manufacturers.
Active projects across Asia, Middle East, Africa, Europe, and LATAM.
Expertise covering oral solids, injectables, APIs, semi-solids, liquids, extracts, oils, and chemicals.
Hands-on regulatory exposure with US FDA, EU Authorities, WHO, PIC/S, and Indian MoH.
Proven success in new product registrations, variations, revalidation, and renewals.
Regulatory Standards We Follow
ValiPro’s process validation documentation aligns with international and national standards:
ICH Q8, Q9, Q10 guidelines.
WHO Technical Report Series (TRS).
US FDA Process Validation Guidance.
EU GMP Guidelines & Annexes.
PIC/S Requirements.
Indian Ministry of Health (MoH) guidelines.
Industries We Serve in India
ValiPro supports a wide range of industries:
Pharmaceuticals & APIs (generics, over-the-counter, biotech).
Cosmetics & Personal Care (skincare, haircare, toiletries).
Herbal, Ayurveda & Natural Extracts (herbal medicines, essential oils).
Essential Oils & Fragrances.
Food & Nutraceutical Ingredients (vitamins, supplements).
Agrochemicals (pesticides, herbicides).
Industrial Chemicals (specialty chemicals, cleaning agents).
Why Indian Companies Choose ValiPro
Regulatory-focused, authority-ready documentation accepted across multiple export markets.
Deep expertise in inspection readiness and query response for Indian manufacturers.
Reduced regulatory observations and rework, ensuring quicker approvals.
Confidential, professional, and deadline-driven execution.
A strong understanding of Indian manufacturing operations, regulatory requirements, and local realities.
How to Get Started
To initiate a project, share the following:
Product and process details.
Dosage form and batch size.
Target export markets (US, EU, etc.).
Submission or inspection timeline.
Existing validation data (if available).
Our team will provide a technical scope and commercial proposal based on your specific needs.