BMRx – Global Batch Manufacturing Record (BMR) Services for Estonia

U GMP–Aligned | Estonian SAM–Compliant | Inspection-Ready

BMRx is a specialized scientific arm of Zoesoe Exports Pvt Ltd, providing end-to-end Batch Manufacturing Record (BMR) Preparation & Review Services for pharmaceutical and regulated-industry manufacturers and MAHs supplying to the Estonian market and the wider European Union.

Since 2008, BMRx has supported manufacturers across Europe and global markets with regulatory-compliant, authority-acceptable BMR documentation, ensuring alignment with the Estonian State Agency of Medicines (SAM), EU GMP, WHO GMP, and global inspection readiness.

Who We Serve in Estonia

We work with Estonia-based and Estonia-focused organizations involved in:

• Manufacturing for the Estonian domestic market (SAM)
• Export to EU, EEA & global regulated markets
• Contract manufacturing (CMOs / CDMOs)
• Technology transfer & scale-up projects
• New manufacturing site approvals & variations
• EU GMP inspections & partner audits

Our BMR Services for Estonia Manufacturers

✅ BMR Preparation

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

• EU GMP Guidelines (EudraLex Volume 4)
• Estonian SAM GMP requirements
• WHO GMP Guidelines
• US FDA cGMP (21 CFR Parts 210 & 211)
• PIC/S GMP Requirements

Key Features
• Non-generic, site-specific BMRs
• Operator-friendly & shop-floor executable formats
• Clearly defined IPCs, CPPs, CQAs & yields
• Inspection-ready documentation acceptable to SAM & EU inspectors

✅ BMR Review & GMP Compliance Check

Independent technical and GMP review of existing BMRs to identify:

• Missing EU / Estonian GMP elements
• Data integrity (ALCOA+) gaps
• Inspection-critical weaknesses
• Non-alignment with current EU GMP expectations

Deliverables include clear, implementable remediation recommendations.

✅ Regulatory Query & Inspection Support

Support during:

• Estonian SAM post-submission queries
• EU GMP inspections & follow-ups
• Partner & customer audits
• Export-market regulatory reviews

Including:
• Authority query responses
• Inspection observation remediation
• CAPA-linked BMR updates

✅ Gap Assessment & Remediation

Comprehensive gap analysis of existing BMRs against:

• EU GMP (EudraLex Vol. 4)
• Estonian SAM expectations
• PIC/S & export-market requirements

With practical, floor-ready corrective actions suitable for EU-regulated manufacturing environments.

✅ Customized BMR Templates

Provision of ready-to-use, regulator-accepted BMR templates, customized based on:

• Dosage form
• Equipment & batch size
• Manufacturing & packaging process
• Facility layout & utilities
• Target EU & international markets

Our Global Experience (Supporting Estonia from India)

• 3000+ BMRs prepared & reviewed
• Operational since 2008
• Experience across:
– Estonia
– European Union & EEA
– CIS & Eurasia
– Middle East
– Asia
– LATAM

Product Categories Supported
• Finished dosage forms
• APIs & intermediates
• Advanced therapy & sterile products
• Herbal & traditional medicines
• Nutraceuticals & food ingredients
• Cosmetics & personal care

Regulatory Interaction Experience With
• Estonian State Agency of Medicines (SAM)
• EU Authorities
• WHO
• US FDA
• PIC/S Regulators

Regulatory Standards Followed

All BMR documentation is prepared in accordance with:

• EU GMP (EudraLex Volume 4)
• Estonian SAM GMP Guidelines
• WHO GMP
• US FDA cGMP (21 CFR 210 & 211)
• PIC/S GMP Requirements
• ICH Q7 / Q8 / Q9 / Q10 (where applicable)

Industries We Support in Estonia

• Pharmaceutical Finished Dosage Forms
• APIs & Bulk Drugs
• Sterile & Biologics Manufacturing
• Herbal & Traditional Products
• Nutraceuticals & Food Ingredients
• Cosmetics & Personal Care

Why Estonia Market Companies Choose BMRx

• 🇪🇪 Strong understanding of EU & Estonian GMP expectations
• 🌍 Export-oriented BMRs accepted across the EU & globally
• 📋 Inspection-ready, auditable documentation
• 🔍 Reduced EU inspection & regulatory observations
• 🧠 Integrated technical, GMP & regulatory expertise
• 🛠️ Non-generic, process-specific BMRs
• 🔒 Confidential, professional & deadline-driven delivery
• 👷 Operator-friendly formats for EU shop-floor execution

How We Initiate a BMR Project

To initiate BMR preparation or review, we typically require:

• Product & formulation details
• Manufacturing / packaging process & flow diagram
• Equipment list & batch size
• Target markets & regulatory pathway
• 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 Estonian manufacturers for EU, EEA & global regulatory success.