BMRx – Batch Manufacturing Record (BMR) Services in Ahmedabad

CDSCO | State FDA Gujarat | US FDA | EU GMP | WHO | PIC/S Compliant
Inspection-Ready | Export-Focused | Ahmedabad Manufacturing Aligned

BMRx is a specialized scientific arm of Zoesoe Exports Pvt Ltd, providing end-to-end Batch Manufacturing Record (BMR) Preparation, Review, and Remediation Services for pharmaceutical and manufacturing companies in Ahmedabad and Gujarat supplying to Indian and international regulated markets.

Since 2008, BMRx has supported Ahmedabad-based pharmaceutical, API, cosmetic, herbal, food, and chemical manufacturers with regulatory-compliant, authority-acceptable BMR documentation, enabling smooth approvals, inspection readiness, and reduced regulatory observations.

Who We Serve in Ahmedabad & Gujarat

We work closely with manufacturers involved in:

• Manufacturing for Indian market (CDSCO & Gujarat State FDA)
• Export to US, EU, UK, ASEAN, GCC, Africa & LATAM
• Pharmaceutical CMOs & CDMOs in Ahmedabad clusters
• API & finished dosage form manufacturing
• Technology transfer & scale-up projects
• New plant / new line / new product approvals
• Companies preparing for US FDA, EU GMP, WHO, CDSCO inspections

Our BMR Services for Ahmedabad Manufacturers

✅ BMR Preparation

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

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

Key Features
• Non-generic, equipment-specific BMRs
• Operator-friendly shop-floor formats
• Data-integrity-focused documentation
• Inspection-ready and audit-defensible

✅ BMR Review & GMP Compliance Check

Independent technical and GMP review of existing BMRs to identify:

• Missing GMP and compliance elements
• Data integrity and documentation gaps
• Inspection-critical weaknesses
• Misalignment with export market expectations

Outcome: Corrected, strengthened BMRs aligned with current Indian and global GMP requirements.

✅ Regulatory Query & Inspection Support

Support for BMR-related queries during:

• CDSCO / Gujarat State FDA inspections
• US FDA audits
• EU GMP & WHO inspections
• Post-inspection CAPA implementation

Includes BMR corrections, justifications, and regulator-acceptable responses.

✅ Gap Assessment & Remediation

• Gap analysis of existing BMRs against:
– Updated Schedule M
– US FDA / EU GMP expectations
– Export country MOH requirements
• Practical, floor-ready corrective actions
• Alignment with validation and quality systems

✅ Customized BMR Templates

• Ready-to-use, regulator-accepted BMR templates
• Customized based on:
– Dosage form
– Equipment & batch size
– Manufacturing process
– Facility layout & utilities
– Target domestic and export markets

Our Experience (Strong Presence in Gujarat)

• 3000+ BMRs prepared and reviewed
• Operational since 2008
• Extensive experience with Ahmedabad & Gujarat manufacturing clusters
• Exposure across:
– India
– US
– Europe
– Middle East
– Africa
– LATAM

Product Categories Covered
• APIs & intermediates
• Finished dosage forms
• Cosmetics & personal care
• Herbal & Ayurveda products
• Food & nutraceutical ingredients
• Chemicals & agrochemicals

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 requirements for exports

Industries We Support in Ahmedabad

• Pharmaceuticals & APIs
• Formulation manufacturing units
• Contract manufacturing organizations (CMOs/CDMOs)
• Cosmetics & personal care
• Herbal & nutraceutical manufacturers
• Industrial & specialty chemicals

Why Ahmedabad Manufacturers Choose BMRx

• 🏭 Deep understanding of Ahmedabad manufacturing practices
• 🌍 Export-oriented, globally acceptable BMRs
• 📋 Inspection-ready documentation
• 🔍 Reduced regulatory and data-integrity observations
• 🧠 Technical + GMP + regulatory expertise
• 🛠️ Process-specific, non-generic BMRs
• 🔒 Confidential, professional, deadline-driven execution
• 👷 Operator-friendly records for real shop-floor use

How We Start the Project

To initiate BMR preparation or review, we typically request:

• Product and formulation details
• Manufacturing process & flow diagrams
• Equipment list and batch size
• Target 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 Ahmedabad manufacturers for India and global regulatory success.