BMRx – Batch Manufacturing Record (BMR) Services in Roorkee

Uttarakhand State FDA | CDSCO | US FDA | EU GMP | WHO | PIC/S Compliant
Formulation & Export Hub Focused | 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, nutraceutical, and allied manufacturers in Roorkee and the Uttarakhand industrial belt supplying to Indian and international regulated markets.

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

Who We Serve in Roorkee & Uttarakhand

We work closely with companies involved in:

• Pharmaceutical formulation manufacturing
• APIs, intermediates & bulk drugs
• Oral solid dosage (OSD) & non-OSD products
• Pharmaceutical CMOs & CDMOs
• Manufacturing for Indian market (CDSCO & Uttarakhand 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 Roorkee Manufacturers

✅ BMR Preparation

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

• Indian GMP (Schedule M)
• Uttarakhand 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 (tablets, capsules, liquids, topicals, etc.)
• Equipment- and batch-size-specific documentation
• Strong control of CPPs, IPCs & 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 documentation elements
• Data integrity, traceability & ALCOA+ gaps
• Inadequate in-process control documentation
• Inspection-critical weaknesses observed during audits

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

✅ Regulatory Query & Inspection Support

Support for BMR-related queries during:

• Uttarakhand 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 Roorkee Pharma Cluster

• 3000+ BMRs prepared and reviewed
• Operational since 2008
• Extensive experience with Roorkee, Haridwar, SIDCUL, Dehradun industrial zones
• Strong exposure to export-oriented formulation facilities

Product Categories Covered
• Finished dosage forms
• APIs & intermediates
• Nutraceutical & herbal products
• Cosmetics & personal care
• Specialty chemical 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 Roorkee

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

Why Roorkee Manufacturers Choose BMRx

• 🏭 Strong understanding of Roorkee & Uttarakhand 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 Roorkee manufacturers for India and global regulatory success