BMRx – Global Batch Manufacturing Record (BMR) Services in Visakhapatnam

ndia-Compliant | Export-Oriented | 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 pharmaceutical, API, formulation, and chemical manufacturers in Visakhapatnam (Vizag) supplying to Indian and international regulated markets.

Since 2008, BMRx has supported large export-oriented plants and emerging manufacturers across Andhra Pradesh and India with regulatory-compliant, authority-acceptable BMR documentation, ensuring smooth approvals, inspection readiness, and reduced regulatory observations.

Who We Serve in Visakhapatnam

We work closely with Vizag-based companies involved in:

• API & intermediate manufacturing
• Finished dosage formulations (OSD, injectables, liquids, semi-solids)
• Export-oriented units (US FDA / EU / WHO markets)
• Contract manufacturing (CMOs & CDMOs)
• New manufacturing site approvals
• Technology transfer & scale-up
• Regulatory inspections and GMP audits

Our BMR Services for Visakhapatnam Manufacturers

We provide complete lifecycle support for Batch Manufacturing Records, including:

✅ BMR Preparation

• Preparation of product-specific, process-driven BMRs aligned with:
o Indian GMP (Schedule M)
o US FDA (21 CFR Parts 210 & 211)
o EU GMP
o WHO GMP
o PIC/S GMP
• Non-generic, shop-floor-ready BMRs for APIs and formulations
• Clear documentation of CPPs, IPCs, yields, reconciliation, and deviations
• Operator-friendly formats for large-scale commercial batches

✅ BMR Review & GMP Compliance Check

• Independent technical, GMP, and data-integrity review of existing BMRs
• Identification of:
o Missing GMP elements
o Data-integrity and traceability gaps
o US FDA / EU inspection-critical weaknesses
• Alignment with current regulatory and inspection expectations

✅ Regulatory Query & Inspection Support

• Support during AP State FDA, CDSCO, US FDA, EU, and WHO inspections
• Handling of BMR-related observations and authority queries
• CAPA-linked BMR corrections and upgrades
• Post-inspection remediation support

✅ Gap Assessment & Remediation

• Detailed gap analysis of existing BMRs against:
o Updated Schedule M & global GMP guidelines
o Export market expectations
• Practical, floor-executable corrective actions
• Risk-based remediation for injectables, sterile operations, and APIs

✅ Customized BMR Templates

• Regulator-accepted, ready-to-use BMR templates
• Custom-built based on:
o Dosage form & manufacturing technology
o Equipment trains & batch size
o Facility layout & utilities (HVAC, WFI, cleanrooms)
o Export and customer audit requirements

Our Experience in Visakhapatnam & Andhra Pradesh

• 3000+ BMRs prepared and reviewed
• Operational since 2008
• Strong exposure to Visakhapatnam, Parawada, Atchutapuram, Kakinada, Hyderabad clusters
• Extensive experience with:
o APIs & intermediates
o Oral solid dosage forms
o Injectables & sterile products
o Semi-solids & liquids
o Chemicals & industrial intermediates
• Regular interaction with:
o AP State FDA
o CDSCO
o US FDA
o EU authorities
o WHO / PIC/S inspectors

Regulatory Standards Followed

All BMR documentation is prepared in line with:

• Indian GMP (Schedule M)
• WHO GMP Guidelines
• US FDA cGMP (21 CFR Parts 210 & 211)
• EU GMP Guidelines
• PIC/S GMP Requirements
• ICH Q7 / Q8 / Q9 / Q10
• Customer- and country-specific export requirements

Industries We Support in Visakhapatnam

• APIs & Intermediates
• Finished Dosage Forms
• Injectables & Sterile Products
• Bulk Drugs
• Specialty & Fine Chemicals
• Agrochemicals
• Cosmetics & Personal Care
• Food & Nutraceutical Ingredients

Why Visakhapatnam Manufacturers Choose BMRx

• 🏭 Strong understanding of Vizag export manufacturing ecosystem
• 🌍 US FDA / EU / WHO inspection-ready BMRs
• 📋 Audit-ready, traceable documentation
• 🔍 Reduced regulatory observations
• 🧠 Technical + GMP + regulatory expertise
• 🛠️ Non-generic, process-specific BMRs
• 🔒 Confidential, professional, and deadline-driven
• 👷 Operator-friendly formats for shop-floor execution

How We Start the Project

To initiate BMR preparation or review, we typically require:

• Product & formulation details
• Manufacturing process & flow diagram
• Equipment list and batch size
• Target export markets and 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 Visakhapatnam manufacturers for India & global regulatory success