BMRx – Batch Manufacturing Record (BMR) Services in Pune

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

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, API, biotech, and life-science manufacturers in Pune and the Pimpri–Chinchwad region supplying to Indian and international regulated markets.

Since 2008, BMRx has supported Pune-based formulation plants, API units, biologics facilities, CDMOs, and R&D-driven organizations with regulatory-compliant, authority-acceptable BMR documentation, enabling smooth approvals, inspection readiness, and reduced regulatory observations.

Who We Serve in Pune & PCMC

We work closely with companies involved in:

• Pharmaceutical & formulation manufacturing
• APIs, intermediates & bulk drugs
• Biologics, vaccines & sterile products
• Pharmaceutical CMOs & CDMOs
• Manufacturing for Indian market (CDSCO & Maharashtra State FDA)
• Export to US, EU, UK, ASEAN, GCC, Africa & LATAM
• Technology transfer, scale-up & lifecycle management projects
• Companies preparing for US FDA, EU GMP, WHO, CDSCO inspections

Our BMR Services for Pune 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
• R&D-to-commercial transfer–friendly BMRs
• Dosage-form and product-class-specific documentation
• Strong control of CPPs, IPCs & reconciliation
• Data-integrity-focused, audit-defensible records
• Operator-friendly shop-floor execution

✅ 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 controls or recording practices
• Inspection-critical weaknesses highlighted in 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 / product class
– Equipment & batch size
– Manufacturing process
– Facility layout, cleanrooms & utilities
– Target domestic & export markets

Our Experience in Pune Pharma & Biotech Ecosystem

• 3000+ BMRs prepared and reviewed
• Operational since 2008
• Extensive experience with Pune, Pimpri–Chinchwad, Hinjewadi, Talegaon, Chakan industrial clusters
• Strong exposure to R&D-led manufacturing and global regulatory interfaces

Product Categories Covered
• Finished dosage forms
• APIs & intermediates
• Sterile injectables
• Biologics & vaccines
• 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 Pune

• Pharmaceutical formulations
• APIs & intermediates
• Biotech, biologics & sterile manufacturing
• Contract manufacturing (CMOs/CDMOs)
• Nutraceutical & herbal manufacturers
• Export-oriented manufacturing units

Why Pune Manufacturers Choose BMRx

• 🧪 Strong understanding of R&D-driven manufacturing environments
• 🌍 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 Pune manufacturers for India and global regulatory success