ValiPro -Global Process Validation Protocol & Report Services

ValiPro -Global Process Validation Protocol & Report Services

ValiPro is a specialized scientific arm of Zoesoe Exports Pvt Ltd, delivering end-to-end Process Validation Protocol and Report Preparation & Review Services for regulated global markets.

Since 2008, ValiPro has been supporting manufacturers with regulatory-compliant, authority-acceptable validation documentation, ensuring smooth approvals and minimal regulatory queries.

What We Do

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

• MOH / FDA query handling related to validation (post-submission)

• Gap assessment against country-specific GMP and validation guidelines

• Supply of ready-to-use validation templates

All documents are tailored to product type, manufacturing process, dosage form, and target market requirements.

Our Experience

• 870+ products supported globally

• Active across Asia, Middle East, Africa, Europe & LATAM

• Experience across multiple dosage forms, APIs, and industrial processes

• Regulatory exposure with US FDA, EU, WHO, PIC/S & country MOHs

• Proven track record in new submissions, variations, and renewals

Regulatory Standards Followed

Our validation documentation aligns with:

• ICH Q8, Q9, Q10

• WHO TRS Guidelines

• US FDA Process Validation Guidance

• EU GMP Annexes

• PIC/S Requirements

• Country-specific MOH expectations

Industries We Serve

• Pharmaceuticals & APIs

• Cosmetics & Personal Care

• Herbal, Ayurveda & Natural Extracts

• Essential Oils & Fragrances

• Food & Nutraceutical Ingredients

• Agrochemicals

• Industrial Chemicals

Why Choose ValiPro

• Regulatory-focused, non-generic documentation

• Templates accepted across multiple regions

• Strong experience in authority query resolution

• Faster approvals with reduced observations

• Confidential, professional, and deadline-driven execution

“Validation Documentation Regulators Accept”

Excellence in Process Validation Research & Compliance.

📌 Frequently Asked Questions (FAQ) – ValiPro -Global Process Validation Protocol & Report Services

1. What services does ValiPro provide?

ValiPro provides preparation and technical review of Process Validation Protocols and Process Validation Reports, along with post-submission regulatory query handling related to validation documentation.

2. Which industries does ValiPro support?

We support:

• Pharmaceuticals & APIs

• Cosmetics & Personal Care

• Herbal, Ayurveda & Natural Extracts

• Essential Oils & Fragrances

• Food & Nutraceutical Ingredients

• Agrochemicals

• Industrial Chemicals

3. Which regulatory guidelines do you follow?

Our validation documents are prepared in accordance with:

• ICH Q8, Q9, Q10

• WHO TRS guidelines

• US FDA Process Validation Guidance

• EU GMP requirements

• PIC/S guidelines

• Country-specific MOH regulations

4. Do you prepare documents for global submissions?

Yes. ValiPro has experience supporting submissions for Asia, Middle East, Africa, Europe, and LATAM markets, with documentation tailored to local regulatory expectations.

5. Can you handle MOH / FDA queries after submission?

Yes. We provide post-submission regulatory support, including preparation of scientifically justified responses to MOH, FDA, and other authority queries related to process validation.

6. Do you work with existing validation data?

Yes. We can:

• Review existing protocols and reports

• Perform gap assessments

• Upgrade documents to meet current regulatory expectations

• Convert legacy documents into authority-acceptable formats

7. Do you have ready-to-use validation templates?

Yes. We maintain regulator-accepted, ready-to-use templates that can be customized based on:

• Product type

• Manufacturing process

• Dosage form

• Target market

8. How many products has ValiPro supported?

ValiPro has supported 870+ products globally across multiple regulatory regions since 2008.

9. Is ValiPro involved in on-site execution of validation?

ValiPro focuses on documentation, technical justification, and regulatory compliance. On-site execution is coordinated with the manufacturer’s production and quality teams.

10. How do you ensure confidentiality of client data?

All client information is handled under strict confidentiality and data protection practices, with documents shared only with authorized personnel.

11. Can ValiPro support both new products and variations?

Yes. We support:

• New product registrations

• Process changes and variations

• Scale-up and technology transfer

• Renewal and revalidation submissions

12. How can we initiate a project with ValiPro?

You can initiate a project by sharing:

• Product and process details

• Target markets

• Submission timeline

• Existing validation data (if any)

Our team will provide a technical scope and commercial proposal accordingly.