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

TİTCK–Aligned | EU & PIC/S GMP 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 in Turkey supplying to domestic and international regulated markets.

Since 2008, BMRx has supported manufacturers across Europe, the Middle East, and global export markets with regulatory-compliant, authority-acceptable BMR documentation, ensuring alignment with Turkish Medicines and Medical Devices Agency (TİTCK) requirements, EU GMP, PIC/S GMP, and global inspection readiness.

Who We Serve in Turkey

We work with Turkey-based organizations involved in:

• Manufacturing for the Turkey domestic market (TİTCK)
• Export to EU, UK, MENA, CIS, Africa & LATAM
• Contract manufacturing (CMOs / CDMOs)
• Technology transfer, localization & EU harmonization projects
• New manufacturing site approvals & license renewals
• TİTCK, EU GMP & customer inspections

Our BMR Services for Turkey Manufacturers

✅ BMR Preparation

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

• TİTCK GMP requirements
• EU GMP Guidelines (EudraLex Vol. 4)
• PIC/S GMP Requirements
• WHO GMP Guidelines
• US FDA cGMP (21 CFR Parts 210 & 211)

Key Features:
• Non-generic, facility-specific BMRs
• EU-style, inspection-ready documentation
• Operator-friendly & shop-floor executable formats
• Clear in-process controls, yields & CPPs

✅ BMR Review & EU / PIC/S GMP Compliance Check

Independent technical and GMP review of existing BMRs to identify:

• Missing TİTCK / EU GMP elements
• Data integrity & ALCOA+ gaps
• Inspection-critical weaknesses
• Non-alignment with EU export expectations

Deliverables include clear, implementable remediation recommendations.

✅ Regulatory Query & Inspection Support

Support during:

• TİTCK post-submission queries
• EU GMP inspections & follow-ups
• PIC/S audits & customer inspections
• Export market regulatory reviews

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

✅ Gap Assessment & Remediation

Comprehensive gap analysis of existing BMRs against:

• TİTCK GMP requirements
• EU GMP & PIC/S expectations
• WHO GMP & export-market MOH requirements

With practical, floor-ready corrective actions suitable for Turkish 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 domestic & export markets

Our Global Experience (Supporting Turkey from India)

• 3000+ BMRs prepared & reviewed
• Operational since 2008
• Experience across:
– Turkey
– EU & Eastern Europe
– Middle East
– Asia
– Africa
– LATAM

Product Categories Supported:
• Finished dosage forms
• APIs & intermediates
• Cosmetics & personal care
• Herbal & traditional medicines
• Nutraceuticals & food ingredients
• Chemicals & agrochemicals

Regulatory Interaction Experience With:
• TİTCK – Turkey
• EU Authorities
• WHO
• US FDA
• PIC/S Regulators

Regulatory Standards Followed

All BMR documentation is prepared in accordance with:

• TİTCK GMP Guidelines
• EU GMP (EudraLex Vol. 4)
• PIC/S GMP Requirements
• WHO GMP
• US FDA cGMP (21 CFR 210 & 211)
• ICH Q7 / Q8 / Q9 / Q10 (where applicable)
• Country-specific MOH expectations for exports

Industries We Support in Turkey

• Pharmaceutical Finished Dosage Forms
• APIs & Bulk Drugs
• Herbal & Traditional Medicines
• Nutraceuticals & Food Ingredients
• Cosmetics & Personal Care
• Agrochemicals
• Industrial Chemicals

Why Turkey Manufacturers Choose BMRx

• 🇹🇷 Strong understanding of TİTCK, EU & PIC/S GMP expectations
• 🌍 Export-oriented BMRs accepted across EU & global markets
• 📋 Inspection-ready & auditable documentation
• 🔍 Reduced regulatory & inspection observations
• 🧠 Integrated technical, GMP & regulatory expertise
• 🛠️ Non-generic, process-specific BMRs
• 🔒 Confidential, professional & deadline-driven delivery
• 👷 Operator-friendly formats for 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 Turkish manufacturers for EU and global regulatory success