BMRx – Batch Manufacturing Record (BMR) Services in Hyderabad

Telangana State FDA | CDSCO | US FDA | EU GMP | WHO | PIC/S Compliant
API & Pharma 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 Hyderabad and Telangana supplying to Indian and international regulated markets.

Since 2008, BMRx has supported Hyderabad-based API parks, formulation plants, biologics facilities, and CDMOs with regulatory-compliant, authority-acceptable BMR documentation, enabling smooth approvals, US FDA readiness, and reduced regulatory observations.

Who We Serve in Hyderabad & Telangana

We work closely with companies involved in:

• API & bulk drug manufacturing
• Pharmaceutical formulation units
• Biologics, biosimilars & vaccines
• Pharmaceutical CMOs & CDMOs
• Manufacturing for Indian market (CDSCO & Telangana 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 Hyderabad Manufacturers

✅ BMR Preparation

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

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

Key Features
• Reactor-wise & equipment-specific BMRs for APIs
• Dosage-form-specific BMRs for formulations
• Strong control of CPPs, IPCs & yield reconciliation
• Data-integrity-focused, audit-defensible formats
• Operator-friendly shop-floor execution

✅ BMR Review & GMP Compliance Check

Independent technical and GMP review of existing BMRs to identify:

• Missing GMP or ICH Q7 elements
• Inadequate CPP, IPC, or yield documentation
• Data integrity & traceability gaps (ALCOA+)
• Inspection-critical weaknesses observed in US FDA audits

Outcome: Corrected, strengthened BMRs aligned with current global regulatory expectations.

✅ Regulatory Query & Inspection Support

Support for BMR-related queries during:

• Telangana State FDA & CDSCO inspections
• US FDA inspections (API & formulation)
• 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
– ICH Q7 (API GMP)
– US FDA & EU GMP expectations
• Practical, plant-ready corrective actions
• Alignment with validation, cleaning & quality systems

✅ Customized BMR Templates

• Ready-to-use, regulator-accepted BMR templates
• Customized based on:
– API / formulation process
– Reactor / equipment & batch size
– Manufacturing scale & plant layout
– Utilities & cleanroom classification
– Target domestic & export markets

Our Experience in Hyderabad Pharma Ecosystem

• 3000+ BMRs prepared and reviewed
• Operational since 2008
• Extensive experience with Hyderabad, Genome Valley, Jeedimetla, Bollaram, Pashamylaram, IDA Uppal clusters
• Strong exposure to US FDA–regulated API & formulation facilities

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

Regulatory Standards Followed

All BMR documentation is prepared in line with:

• Indian GMP (Schedule M)
• ICH Q7 (API GMP)
• WHO GMP Guidelines
• US FDA cGMP (21 CFR 210 & 211)
• EU GMP Guidelines
• PIC/S GMP Requirements
• ICH Q8, Q9, Q10 (where applicable)
• Country-specific MOH requirements for exports

Industries We Support in Hyderabad

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

Why Hyderabad Manufacturers Choose BMRx

• 🧪 Deep understanding of API & formulation manufacturing realities
• 🌍 Export-oriented, globally acceptable BMRs
• 📋 Inspection-ready, audit-defensible documentation
• 🔍 Reduced US FDA & EU GMP observations
• 🧠 Strong 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 / API details
• Manufacturing process & flow diagrams
• Reactor & equipment list
• Batch size & scale
• Target export markets
• 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 Hyderabad manufacturers for India and global regulatory success.