BMRx – Batch Manufacturing Record (BMR) Services in Baddi

Himachal Pradesh State FDA | CDSCO | US FDA | EU GMP | WHO | PIC/S Compliant
Formulation 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 formulation manufacturers in Baddi and the Nalagarh–Barotiwala industrial belt supplying to Indian and international regulated markets.

Since 2008, BMRx has supported Baddi-based tablet, capsule, liquid, injectable, and OSD manufacturing units with regulatory-compliant, authority-acceptable BMR documentation, enabling smooth approvals, inspection readiness, and reduced regulatory observations.

Who We Serve in Baddi & Nalagarh Region

We work closely with companies involved in:

• Finished dosage form manufacturing (OSD & non-OSD)
• Pharmaceutical CMOs & CDMOs
• Manufacturing for Indian market (CDSCO & HP State FDA)
• Export to US, EU, UK, ASEAN, GCC, Africa & LATAM
• New product, new line, and tech transfer projects
• Companies preparing for US FDA, EU GMP, WHO, CDSCO inspections

Our BMR Services for Baddi Manufacturers

✅ BMR Preparation

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

• Indian GMP (Schedule M)
• Himachal Pradesh State FDA expectations
• US FDA cGMP (21 CFR Parts 210 & 211)
• EU GMP Guidelines
• WHO GMP
• PIC/S GMP Requirements

Key Features
• Dosage-form-specific BMRs (tablets, capsules, syrups, injectables, etc.)
• Clear, operator-friendly shop-floor formats
• Strong control of CPPs, IPCs, and reconciliation
• Data-integrity and audit-trail-focused documentation

✅ BMR Review & GMP Compliance Check

Independent technical and GMP review of existing BMRs to identify:

• Missing GMP and documentation elements
• Data integrity gaps and reconciliation issues
• Inadequate in-process control recording
• Inspection-critical weaknesses observed in audits

Outcome: Strengthened, compliant BMRs aligned with current Indian and global GMP expectations.

✅ Regulatory Query & Inspection Support

Support for BMR-related queries during:

• HP State FDA & CDSCO inspections
• US FDA audits
• EU GMP & WHO 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
– Export market MOH 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 and export markets

Our Experience in Baddi Pharmaceutical Cluster

• 3000+ BMRs prepared and reviewed
• Operational since 2008
• Extensive experience with Baddi, Nalagarh, Barotiwala formulation hubs
• Exposure across regulated global markets

Product Categories Covered
• Tablets & capsules
• Oral liquids & suspensions
• Topicals & semisolids
• Injectables & sterile products
• Nutraceutical & herbal formulations

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 Q8, Q9, Q10 (where applicable)
• Country-specific MOH requirements for exports

Industries We Support in Baddi

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

Why Baddi Manufacturers Choose BMRx

• 🏭 Deep understanding of Baddi formulation manufacturing
• 🌍 Export-oriented, globally acceptable BMRs
• 📋 Inspection-ready, audit-defensible documentation
• 🔍 Reduced regulatory and data-integrity 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 and formulation details
• Manufacturing process & flow diagram
• 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 Baddi manufacturers for India and global regulatory success