BMRx – Global Batch Manufacturing Record (BMR) Services

BMRx – Global Batch Manufacturing Record (BMR) Services

Regulatory-Compliant | Authority-Ready | Globally Trusted

BMRx is a specialized scientific arm of Zoesoe Exports Pvt Ltd, providing end-to-end Batch Manufacturing Record (BMR) Preparation and Review Services for regulated global markets.

Since 2008, BMRx has been supporting manufacturers worldwide with regulatory-compliant, authority-acceptable BMR documentation, ensuring smooth approvals, inspection readiness, and effective responses to regulatory authorities.

What We Do

We provide complete lifecycle support for BMR documentation, including:

• Preparation of Batch Manufacturing Records (BMRs) as per country-specific regulations

• Independent technical and GMP review of existing BMRs

• MOH / FDA / Health Authority query handling related to BMRs (post-submission or post-inspection)

• Gap assessment of existing BMRs against current GMP requirements

• Customization of BMRs based on product type, process, equipment, and dosage form

• Supply of regulator-accepted, ready-to-use BMR templates

All BMRs are prepared with a process-driven and compliance-focused approach, ensuring clarity, traceability, and regulatory acceptability.

Our Global Experience

• 3000+ BMRs prepared globally

• Active since 2008

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

• Coverage of APIs, finished dosage forms, cosmetics, food, and chemical products

• Strong exposure to MOH, US FDA, EU Authorities, WHO, PIC/S & country regulators

• Proven success in new registrations, technology transfers, variations, and renewals

Regulatory Standards Followed

Our BMR documentation is prepared in alignment with:

• WHO GMP Guidelines

• US FDA cGMP (21 CFR Parts 210 & 211)

• EU GMP Guidelines

• PIC/S GMP Requirements

• ICH Q7 / Q8 / Q9 / Q10 (where applicable)

• Country-specific MOH GMP expectations

Industries We Serve

• Pharmaceuticals & APIs

• Cosmetics & Personal Care

• Herbal, Ayurveda & Natural Extracts

• Essential Oils & Fragrances

• Food & Nutraceutical Ingredients

• Agrochemicals

• Industrial Chemicals

Why Choose BMRx

• Regulatory-focused, non-generic BMRs

• Templates accepted across multiple global regions

• Strong expertise in inspection and query response

• Clear, auditable, and operator-friendly records

• Reduced regulatory observations and rework

• Confidential, professional, and deadline-driven execution

• Deep understanding of manufacturing floor realities

How We Support You

To initiate BMR preparation or review, we typically require:

• Product and formulation details

• Manufacturing process and flow

• Equipment list and batch size

• Target markets and regulatory pathway

• Existing BMRs (if available)

Based on this information, our team will provide a customized technical scope, timelines, and commercial proposal.

BMRx - Batch Manufacturing Records. Built for Compliance. Ready for Inspection.

“Precision BMRs for Regulated Manufacturing”

Excellence in BMR Research & Compliance.

📌 Frequently Asked Questions (FAQ) – Global Batch Manufacturing Record (BMR) Services

1. What is BMRx?

BMRx is a specialized scientific arm of Zoesoe Exports Pvt Ltd providing global Batch Manufacturing Record (BMR) preparation and review services for regulated industries.

2. What BMR services does BMRx provide?

We provide end-to-end BMR support, including:

• Preparation of Batch Manufacturing Records

• Technical and GMP review of existing BMRs

• Post-submission and post-inspection MOH / FDA query handling

• GMP gap assessment of BMRs

• Customization of BMRs as per product, process, and market

• Supply of regulator-accepted, ready-to-use BMR templates

3. Which regulatory guidelines do you follow for BMR preparation?

Our BMRs are prepared in alignment with:

• WHO GMP guidelines

• US FDA cGMP (21 CFR Parts 210 & 211)

• EU GMP requirements

• PIC/S GMP standards

• ICH Q7, Q8, Q9, Q10 (where applicable)

• Country-specific MOH GMP expectations

4. Do you support global BMR requirements?

Yes. BMRx has experience preparing BMRs for Asia, Middle East, Africa, Europe, and LATAM, tailored to local regulatory and inspection expectations.

5. How many BMRs has BMRx prepared?

Since 2008, BMRx has prepared and reviewed 3000+ BMRs globally across multiple industries and product categories.

6. Can you handle regulatory queries after submission or inspection?

Yes. We provide post-submission and post-inspection support, including preparation of scientifically and GMP-justified responses to MOH, US FDA, EU authorities, and other inspectors.

7. Do you review and upgrade existing BMRs?

Yes. We perform independent GMP reviews, identify gaps, and upgrade legacy BMRs to meet current regulatory and inspection standards.

8. Do you have ready-to-use BMR templates?

Yes. We maintain regulator-accepted BMR templates that are customized based on:

• Product type and dosage form

• Manufacturing process and batch size

• Equipment and facility layout

• Target regulatory market

9. Which industries does BMRx support?

BMRx supports:

• Pharmaceuticals & APIs

• Cosmetics & Personal Care

• Herbal, Ayurveda & Natural Extracts

• Essential Oils & Fragrances

• Food & Nutraceutical Ingredients

• Agrochemicals

• Industrial Chemicals

10. Are BMRs prepared by BMRx operator-friendly?

Yes. Our BMRs are designed to be clear, auditable, and practical for shop-floor execution, while fully compliant with regulatory expectations.

11. Can BMRx support new products and technology transfers?

Yes. We support:

• New product introductions

• Scale-up and technology transfer projects

• Process changes and variations

• Revalidation and renewals

12. How do you ensure data confidentiality?

All client information is handled under strict confidentiality and data protection practices, with controlled access and secure document handling.

13. Can BMRx support Indian manufacturers exporting globally?

Yes. We actively support Indian manufacturers and exporters, aligning BMR documentation with international GMP requirements while considering Indian manufacturing operations.

14. How can we start working with BMRx?

To initiate a project, share basic product and process details. Our team will provide a custom technical scope, timelines, and commercial proposal.

BMRx - Batch Manufacturing Records. Built for Compliance. Ready for Inspection.