BMRx – Global Batch Manufacturing Record (BMR) Services for India

CDSCO & State FDA Compliant | Global GMP Aligned | Inspection-Ready

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

Since 2008, BMRx has supported Indian pharmaceutical, API, cosmetic, herbal, food, and chemical manufacturers with regulatory-compliant, authority-acceptable BMR documentation, ensuring inspection readiness, smooth approvals, and reduced regulatory observations across global audits.

Who We Serve in India

We work with Indian companies involved in:

• Manufacturing for the Indian domestic market (CDSCO & State FDAs)
• Export to US, EU, UK, ASEAN, GCC, Africa & LATAM
• Contract Manufacturing Organizations (CMOs & CDMOs)
• Technology transfer, scale-up & validation projects
• New manufacturing site approvals & expansions
• CDSCO, State FDA, US FDA, EU GMP, WHO & PIC/S inspections

Our BMR Services for Indian Manufacturers

✅ BMR Preparation

We prepare product-specific, process-driven BMRs aligned with:

• Indian GMP – Schedule M (CDSCO & State FDA)
• US FDA cGMP (21 CFR Parts 210 & 211)
• EU GMP Guidelines
• WHO GMP
• PIC/S GMP Requirements

Key Features:
• Non-generic, facility-specific BMRs
• Operator-friendly & shop-floor executable formats
• Clear in-process controls, yields & CPPs
• Inspection-ready documentation accepted globally

✅ BMR Review & GMP Compliance Check

Independent technical and GMP review of existing BMRs to identify:

• Missing Schedule M / GMP elements
• Data integrity & documentation gaps
• Inspection-critical weaknesses
• Non-alignment with export market expectations

Deliverables include clear, practical remediation recommendations.

✅ Regulatory Query & Inspection Support

We support Indian manufacturers during:

• CDSCO & State FDA queries
• US FDA Form 483 / EIR responses
• EU GMP inspection follow-ups
• WHO / PIC/S audits
• Customer & third-party audits

Including:
• Authority query responses
• Observation remediation
• CAPA-linked BMR corrections

✅ Gap Assessment & Remediation

Comprehensive gap analysis of existing BMRs against:

• Indian Schedule M (latest amendments)
• WHO / PIC/S GMP expectations
• US FDA & EU GMP requirements

With practical, shop-floor–ready corrective actions suitable for Indian manufacturing environments.

✅ Customized BMR Templates

Provision of ready-to-use, regulator-accepted BMR templates, customized based on:

• Dosage form
• Equipment & batch size
• Manufacturing process
• Facility layout & utilities
• Target domestic & export markets

Our Global Experience (Rooted in India)

• 3000+ BMRs prepared & reviewed
• Operational since 2008
• Extensive experience across:
– India
– Asia
– Middle East
– Africa
– Europe
– LATAM

Product Categories Supported:
• APIs & Intermediates
• Finished Dosage Forms
• Cosmetics & Personal Care
• Herbal & Ayurveda Products
• Food & Nutraceutical Ingredients
• Chemicals & Agrochemicals

Regulatory Interaction Experience With:
• CDSCO & State FDAs (India)
• US FDA
• EU Authorities
• WHO
• PIC/S Regulators

Regulatory Standards Followed

All BMR documentation is prepared in line with:

• Indian GMP – Schedule M
• WHO GMP Guidelines
• US FDA cGMP (21 CFR 210 & 211)
• EU GMP Guidelines
• PIC/S GMP Requirements
• ICH Q7 / Q8 / Q9 / Q10 (where applicable)
• Country-specific MOH expectations for exports

Industries We Support in India

• Pharmaceuticals & APIs
• Cosmetics & Personal Care
• Herbal, Ayurveda & Natural Extracts
• Nutraceuticals & Food Ingredients
• Agrochemicals
• Industrial Chemicals

Why Indian Manufacturers Choose BMRx

• 🇮🇳 Deep understanding of Indian Schedule M & inspection realities
• 🌍 Export-oriented BMRs accepted by global regulators
• 📋 Inspection-ready & auditable documentation
• 🔍 Reduced regulatory observations
• 🧠 Integrated technical, GMP & regulatory expertise
• 🛠️ Non-generic, process-specific BMRs
• 🔒 Confidential, professional & deadline-driven execution
• 👷 Operator-friendly formats for seamless shop-floor implementation

How We Initiate a BMR Project

To initiate BMR preparation or review, we typically require:

• Product & formulation details
• Manufacturing process & flow diagram
• Equipment list & batch size
• Target markets & regulatory pathway
• Existing BMRs (if available)

Based on this, we provide:

• Customized technical scope
• Clear timelines
• Transparent commercial proposal

BMRx

Batch Manufacturing Records. Built for Compliance. Ready for Inspection.
Supporting Indian manufacturers for global regulatory success.