BMRx – Batch Manufacturing Record (BMR) Services in Panaji–Goa

Goa State FDA | CDSCO | US FDA | EU GMP | WHO | PIC/S Compliant
Export-Oriented | Inspection-Ready | Globally 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, API, cosmetic, and allied manufacturers in Panaji and across Goa supplying to Indian and international regulated markets.

Since 2008, BMRx has supported Goa-based formulation plants, API units, CMOs, and export-focused manufacturers with regulatory-compliant, authority-acceptable BMR documentation, enabling smooth approvals, inspection readiness, and reduced regulatory observations.

Who We Serve in Panaji & Goa

We work closely with companies involved in:

• Pharmaceutical formulation manufacturing
• APIs, intermediates & bulk drugs
• Small and mid-sized export-oriented units
• Pharmaceutical CMOs & CDMOs
• Manufacturing for Indian market (CDSCO & Goa State FDA)
• Export to US, EU, UK, ASEAN, GCC, Africa & LATAM
• Technology transfer, scale-up & capacity expansion projects
• Companies preparing for US FDA, EU GMP, WHO, CDSCO inspections

Our BMR Services for Goa Manufacturers

✅ BMR Preparation

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

• Indian GMP (Schedule M)
• Goa 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 BMRs (OSD, liquids, topicals, etc.)
• Simple, operator-friendly shop-floor formats
• Strong control of CPPs, IPCs & reconciliation
• Data-integrity-focused, audit-defensible documentation

✅ 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:

• Goa 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, shop-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 & export markets

Our Experience in Goa Pharma Manufacturing Cluster

• 3000+ BMRs prepared and reviewed
• Operational since 2008
• Extensive experience with Panaji, Verna, Ponda, Mapusa, Canacona industrial zones
• Strong exposure to export-focused small & mid-sized facilities

Product Categories Covered
• Finished dosage forms
• APIs & intermediates
• Cosmetics & personal care
• Nutraceutical & herbal products
• Chemicals & specialty 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 Goa

• Pharmaceutical formulations
• APIs & intermediates
• Contract manufacturing (CMOs/CDMOs)
• Nutraceutical & herbal manufacturers
• Cosmetics & personal care
• Export-oriented manufacturing units

Why Goa Manufacturers Choose BMRx

• 🌴 Strong understanding of Goa manufacturing ecosystem
• 🌍 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 Panaji–Goa manufacturers for India and global regulatory success.