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

Paraguay-Compliant | DINAVISA & Global GMP Aligned | 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 Paraguayan pharmaceutical, API, cosmetic, herbal, food, and chemical manufacturers supplying to domestic, MERCOSUR, and international regulated markets.

Since 2008, BMRx has supported manufacturers across Latin America, North America, Europe, Africa, Asia, and the Middle East with regulatory-compliant, authority-acceptable BMR documentation, ensuring smooth approvals, inspection readiness, and reduced regulatory observations.

Who We Serve in Paraguay

We work with Paraguay-based companies involved in:

• Manufacturing for the Paraguay domestic market
(DINAVISA – Dirección Nacional de Vigilancia Sanitaria)
• Export to MERCOSUR (Brazil, Argentina, Uruguay), US, EU, Africa & LATAM
• API & intermediate manufacturing
• Finished dosage forms (OSD, liquids, semi-solids, injectables-support)
• Contract manufacturing (CMOs & CDMOs)
• Technology transfer & scale-up projects
• DINAVISA, US FDA, EU GMP & WHO inspections

Our BMR Services for Paraguayan Manufacturers

We provide complete lifecycle support for Batch Manufacturing Records, including:

✅ BMR Preparation

• Preparation of Paraguay-compliant and export-oriented BMRs aligned with:
o DINAVISA GMP requirements
o MERCOSUR GMP guidelines
o US FDA (21 CFR Parts 210 & 211)
o EU GMP (EudraLex Volume 4)
o WHO GMP
o PIC/S GMP
• Product-specific, process-driven, non-generic BMRs
• Clear documentation of CPPs, IPCs, yields, reconciliation, and deviations
• Operator-friendly, inspection-ready formats

✅ BMR Review & GMP Compliance Check

• Independent technical, GMP, and data-integrity review of existing BMRs
• Identification of:
o Missing DINAVISA / MERCOSUR GMP elements
o DINAVISA vs US FDA / EU GMP gaps
o Data integrity and traceability risks
o Inspection-critical weaknesses
• Alignment with current regional and global regulatory expectations

✅ Regulatory Query & Inspection Support

• Support during DINAVISA, US FDA, EU, and WHO inspections
• Handling of BMR-related authority queries:
o Pre-approval inspections
o Routine GMP audits
o For-cause inspections
• CAPA-linked BMR corrections and upgrades

✅ Gap Assessment & Remediation

• Detailed gap analysis of existing BMRs against:
o DINAVISA / MERCOSUR GMP vs US FDA / EU GMP
o Export-market documentation expectations
• Practical, shop-floor-executable corrective actions
• Risk-based remediation for sterile, high-risk, and complex processes

✅ Customized BMR Templates

• Regulator-accepted, ready-to-use BMR templates
• Custom-built based on:
o Dosage form & manufacturing technology
o Equipment trains & batch size
o Facility layout & utilities
o Paraguay domestic and global export requirements

Our Global Experience (Supporting Paraguay from India)

• 3000+ BMRs prepared and reviewed
• Operational since 2008
• Extensive experience supporting Paraguay → MERCOSUR / US / EU / WHO supply chains
• Strong exposure to:
o APIs & intermediates
o Oral solid dosage forms
o Non-sterile formulations
o Export-oriented manufacturing sites
• Regular interaction with:
o DINAVISA
o MERCOSUR regulatory authorities
o US FDA
o EU Competent Authorities
o WHO / PIC/S regulators

Regulatory Standards Followed

All BMR documentation is prepared in line with:

• DINAVISA GMP requirements
• MERCOSUR GMP guidelines
• PIC/S GMP Requirements
• EU GMP (EudraLex Volume 4)
• WHO GMP Guidelines
• US FDA cGMP (21 CFR Parts 210 & 211)
• ICH Q7 / Q9 / Q10
• Import-country MOH and authority expectations

Industries We Support in Paraguay

• Pharmaceuticals & APIs
• Finished Dosage Forms
• Oral Solids, Liquids & Semi-solids
• Cosmetics & Personal Care
• Herbal & Natural Products
• Food & Nutraceutical Ingredients
• Chemicals & Industrial Products

Why Paraguayan Manufacturers Choose BMRx

• 🇵🇾 Strong alignment with DINAVISA & MERCOSUR GMP expectations
• 🌍 Export-oriented BMRs accepted globally
• 📋 Inspection-ready, auditable documentation
• 🔍 Reduced DINAVISA / US FDA / EU GMP observations
• 🧠 Technical + GMP + regulatory expertise
• 🛠️ Non-generic, process-specific BMRs
• 🔒 Confidential, professional, and deadline-driven
• 👷 Operator-friendly formats for shop-floor execution

How We Start the Project

To initiate BMR preparation or review, we typically require:

• Product and formulation details
• Manufacturing process & flow diagram
• Equipment list and batch size
• Target export 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 Paraguayan manufacturers for MERCOSUR & global regulatory success