BMRx – Batch Manufacturing Record (BMR) Services in Thane

Maharashtra State FDA | CDSCO | US FDA | EU GMP | WHO | PIC/S Compliant
MMR Manufacturing Hub Focused | Inspection-Ready | Export-Oriented

BMRx is a specialized scientific arm of Zoesoe Exports Pvt Ltd, delivering end-to-end Batch Manufacturing Record (BMR) Preparation, Review, and Remediation Services for pharmaceutical, API, biotech, and allied manufacturers in Thane and the Mumbai Metropolitan Region (MMR) supplying to Indian and international regulated markets.

Since 2008, BMRx has supported Thane-based formulation units, API manufacturers, CMOs, CDMOs, and export-oriented companies with regulatory-compliant, authority-acceptable BMR documentation, ensuring inspection readiness, smoother approvals, and reduced regulatory observations.

Who We Serve in Thane & MMR

We work closely with companies involved in:

• Pharmaceutical formulation manufacturing
• APIs, intermediates & bulk drugs
• Sterile products, injectables & critical dosage forms
• Pharmaceutical CMOs & CDMOs
• Manufacturing for Indian market (CDSCO & Maharashtra State FDA)
• Export to US, EU, UK, ASEAN, GCC, Africa & LATAM
• Technology transfer, scale-up & multi-site harmonization projects
• Companies preparing for US FDA, EU GMP, WHO, CDSCO inspections

Our BMR Services for Thane Manufacturers

✅ BMR Preparation

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

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

Key Features
• Dosage-form-specific and site-specific BMRs
• Strong control of CPPs, IPCs & reconciliation
• Data-integrity-focused, audit-defensible documentation
• Operator-friendly shop-floor execution formats

✅ BMR Review & GMP Compliance Check

Independent technical and GMP review of existing BMRs to identify:

• Missing GMP or documentation elements
• Data integrity, traceability & ALCOA+ gaps
• Inadequate in-process control documentation
• Inspection-critical weaknesses highlighted during audits

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

✅ Regulatory Query & Inspection Support

Support for BMR-related queries during:

• Maharashtra State FDA & CDSCO inspections
• US FDA audits
• EU GMP & WHO inspections
• Pre-approval & post-approval 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
– WHO & PIC/S requirements
• Practical, site-ready corrective actions
• Alignment with validation, cleaning & 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
– Domestic & export regulatory pathways

Our Experience in Thane Pharma & API Cluster

• 3000+ BMRs prepared and reviewed
• Operational since 2008
• Extensive experience with Thane, Navi Mumbai, Ambernath, Dombivli, Taloja industrial clusters
• Strong exposure to corporate QA, multi-site manufacturing & export-driven facilities

Product Categories Covered
• Finished dosage forms
• APIs & intermediates
• Sterile injectables
• Biologics & biosimilars
• Nutraceuticals & herbal products

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 Thane

• Pharmaceuticals & APIs
• Biotech & sterile manufacturing
• Contract manufacturing (CMOs/CDMOs)
• Nutraceutical & herbal manufacturers
• Cosmetics & personal care
• Export-oriented manufacturing units

Why Thane Manufacturers Choose BMRx

• 🏭 Strong understanding of Thane & MMR manufacturing realities
• 🌍 Export-oriented, globally acceptable BMRs
• 📋 Inspection-ready, audit-defensible documentation
• 🔍 Reduced regulatory & data-integrity observations
• 🧠 Deep 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 strategy
• 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 Thane manufacturers for India and global regulatory success