BMRx – Global Batch Manufacturing Record (BMR) Services for the United States

US FDA cGMP–Aligned | 21 CFR 210/211 Compliant | 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 US-based manufacturers, CMOs, CDMOs, and MAHs, as well as international manufacturers supplying to the US market.

Since 2008, BMRx has supported FDA-regulated facilities worldwide with regulatory-compliant, authority-acceptable BMR documentation, ensuring readiness for US FDA inspections, pre-approval inspections (PAI), routine GMP audits, and for-cause inspections.

Who We Serve in the United States

We work with US-focused organizations involved in:

• Manufacturing for the US domestic market (FDA-regulated products)
• ANDA / NDA / BLA / OTC manufacturing
• Contract manufacturing (CMOs & CDMOs)
• API & intermediate manufacturing
• Technology transfer, scale-up & site change projects
• FDA PAI, routine GMP & for-cause inspections
• Global supply chains sourcing from India, EU, LATAM & Asia

Our BMR Services for US FDA-Regulated Products

✅ BMR Preparation (US FDA Focused)

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

• US FDA cGMP – 21 CFR Parts 210 & 211
• ICH Q7 (APIs)
• ICH Q8 / Q9 / Q10
• EU GMP & PIC/S (for global harmonization)
• WHO GMP (where applicable)

Key Features
• Non-generic, site-specific BMRs
• Clear linkage to Master Batch Records (MBR)
• Defined CPPs, CQAs, IPCs & yield reconciliation
• Data-integrity compliant documentation
• FDA inspection-ready formats

✅ BMR Review & FDA cGMP Compliance Check

Independent technical, GMP & FDA compliance review of existing BMRs to identify:

• Gaps vs 21 CFR 210/211
• Data integrity & ALCOA+ deficiencies
• Inadequate documentation controls
• FDA inspection-critical weaknesses
• Mismatch between process validation & executed records

Includes actionable remediation plans aligned with FDA expectations.

✅ FDA Inspection & Regulatory Query Support

Expert support for:

• FDA 483 observation remediation (BMR-related)
• PAI & NDA/ANDA inspection readiness
• Post-inspection CAPA implementation
• FDA information requests & responses
• Audit support for customer & partner inspections

✅ Gap Assessment & Remediation

Comprehensive BMR gap assessment against:

• Current US FDA cGMP expectations
• FDA inspection trends & warning-letter learnings
• ICH & global GMP alignment

With practical, shop-floor-ready corrective actions.

✅ Customized FDA-Ready BMR Templates

Provision of FDA-acceptable BMR templates, customized based on:

• Dosage form (solid oral, sterile, biologics, APIs, etc.)
• Equipment train & batch size
• Manufacturing & packaging process
• Facility layout & utilities
• US & global regulatory strategy

Our Global Experience (Supporting US Market Products)

• 3000+ BMRs prepared & reviewed
• Operational since 2008
• Extensive experience with:
– US FDA-regulated facilities
– ANDA / NDA / OTC / API manufacturing
– Global CMOs supplying to the US

Product Categories Supported
• Finished dosage forms (OSD, liquids, semi-solids)
• Sterile & injectable products
• APIs & intermediates
• Biologics & vaccines (documentation support)
• OTC & combination products

Regulatory Interaction Experience With
• US Food & Drug Administration (FDA)
• EU Authorities
• WHO
• PIC/S Regulators

Regulatory Standards Followed

All BMR documentation is prepared in line with:

• US FDA cGMP (21 CFR Parts 210 & 211)
• ICH Q7 / Q8 / Q9 / Q10
• EU GMP Guidelines
• PIC/S GMP Requirements
• WHO GMP (where applicable)

Industries We Support in the United States

• Pharmaceutical Finished Dosage Forms
• APIs & Bulk Drugs
• Sterile & Injectable Manufacturing
• Biologics & Vaccines
• OTC & Consumer Health Products

Why US Market Companies Choose BMRx

• 🇺🇸 Deep understanding of US FDA inspection expectations
• 📋 Inspection-ready, auditable BMR documentation
• 🔍 Reduced FDA 483s & warning-letter risk
• 🧠 Strong technical + GMP + regulatory expertise
• 🛠️ Non-generic, process-specific BMRs
• 🔒 Confidential, professional & deadline-driven
• 🌍 Proven experience with global supply chains
• 👷 Operator-friendly execution formats

How We Initiate a BMR Project

To initiate BMR preparation or review, we typically require:

• Product & formulation details
• Manufacturing / packaging process & flow diagrams
• Equipment list & batch size
• Regulatory pathway (ANDA / NDA / OTC / API)
• Existing BMRs / MBRs (if available)

Based on this, we provide:

• Customized technical scope
• Clear timelines
• Transparent commercial proposal

BMRx

Batch Manufacturing Records. Built for FDA Compliance. Ready for Inspection.
Supporting US manufacturers and global suppliers for sustained FDA success.