BMRx – Batch Manufacturing Record (BMR) Services in Chennai

CDSCO-Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, offers complete Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling tailored for formulation companies, CROs, biotech units, and R&D centres based in Chennai, one of India’s most advanced pharmaceutical & clinical research hubs.

All studies comply with:

• CDSCO (Central Drugs Standard Control Organization)

• New Drugs & Clinical Trials Rules (NDCTR), 2019

• ICMR Ethical Guidelines

• ICH GCP & WHO TRS

• GLP for analytical validations

We support submissions to CDSCO/DCGI, as well as export regulatory markets including USFDA, EMA, MHRA, TGA, Health Canada, and others.

💊 Core BA/BE Services for Chennai-Based Pharma & CROs

Clinical BA/BE Studies (Human)

• FDA/EMA-aligned single-dose & multiple-dose BE studies (crossover/parallel).
• Healthy volunteer studies and patient-centric studies depending on therapeutic class.
• Ethics review through CDSCO-registered IECs in Chennai.
• Protocols developed according to ICH E6 (R2), WHO TRS & CDSCO guidance.

Comparative Dissolution Profiling (CDP)

• Mandatory for Form 44 submissions, FDC approvals, and formulation modifications.
• Testing in pharmacopoeial (IP/USP) and biorelevant media (FaSSIF/FeSSIF).
• f2 similarity factor for profile comparison.
• Model-dependent and model-independent approaches.

IVIVC & Biowaiver Support

• BCS-based biowaiver justification per CDSCO, ICH Q6A, and WHO TRS.
• Level A/B/C IVIVC modeling for in vitro–in vivo predictability.
• Dissolution–PK correlation for formulation optimization.

Analytical Method Development & Validation

• LC-MS/MS, HPLC-UV, and stability-indicating methods.
• Bioanalytical method validation per ICH M10 & CDSCO standards.
• Stability studies for API & finished dosage forms.

Pharmacokinetic (PK) & Statistical BE Analysis

• Non-compartmental analysis (NCA) using validated platforms.
• BE evaluation via 90% CI acceptance range.
• Sample-size & power calculations based on intra-subject variability.

📑 CDSCO-Compliant Documentation for Chennai Submissions

We prepare full documentation required for DCGI submissions:

• Clinical Study Protocol
• Informed Consent Form (ICF)
• Investigator Brochure
• Clinical Study Report (CSR) — as per CDSCO & ICH E3 structure
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules (1–5) applicable to Form 44 filings

✨ Why Choose BioEquiGlobal for Chennai?

• Strong Presence in Southern India’s Pharma Corridor: Chennai, Hosur, and Sriperumbudur clusters supported effectively.
• Regulatory Expertise: Depth of experience in NDCTR & CDSCO-compliant BE studies and dissolution requirements.
• Advanced R&D Infrastructure: NABL-certified analytical labs and accredited clinical units accessible nearby.
• Export-Ready Dossier Development: ANDA, CTD, eCTD preparation for global regulatory agencies.
• End-to-End Support: From dissolution development to regulatory filing.

🗺️ BA/BE Study Workflow for Chennai Sponsors

1. Feasibility & Regulatory Assessment
   (Reference product identification, CDSCO gap review, biowaiver evaluation)

2. Protocol Design & IEC Approval
   (Ethics board approval through Chennai-based IECs)

3. Analytical Method Development & Validation
   (LC-MS/MS method development aligned with ICH M10)

4. Clinical Study Execution
   (GCP-compliant dosing, sampling, oversight, safety monitoring)

5. Bioanalysis & PK/BE EvaluationTamil Nadu State FDA | CDSCO | US FDA | EU GMP | WHO | PIC/S Compliant
   Pharma & API 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, API, biotech, and life-science manufacturers in Chennai and Tamil Nadu supplying to Indian and international regulated markets.

   Since 2008, BMRx has supported Chennai-based formulation units, API manufacturers, biologics facilities, and CDMOs with regulatory-compliant, authority-acceptable BMR documentation, enabling smooth approvals, inspection readiness, and reduced regulatory observations.

   Who We Serve in Chennai & Tamil Nadu

   We work closely with companies involved in:

   • Pharmaceutical & API manufacturing
   • Biologics, vaccines & sterile products
   • APIs, intermediates & bulk drugs
   • Pharmaceutical CMOs & CDMOs
   • Manufacturing for Indian market (CDSCO & Tamil Nadu State FDA)
   • Export to US, EU, UK, ASEAN, GCC, Africa & LATAM
   • Technology transfer, scale-up & lifecycle management projects
   • Companies preparing for US FDA, EU GMP, WHO, CDSCO inspections

   Our BMR Services for Chennai Manufacturers

   ✅ BMR Preparation

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

   • Indian GMP (Schedule M)
   • Tamil Nadu 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 and product-class-specific BMRs
   • Sterile, biologics & vaccine-focused 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 controls or recording practices
   • Inspection-critical weaknesses seen in audits

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

   ✅ Regulatory Query & Inspection Support

   Support for BMR-related queries during:

   • Tamil Nadu State FDA & CDSCO inspections
   • US FDA audits
   • EU GMP & WHO inspections
   • Biologics & vaccine-specific 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, sterilization & quality systems

   ✅ Customized BMR Templates

   • Ready-to-use, regulator-accepted BMR templates
   • Customized based on:
   – Dosage form / product class
   – Equipment & batch size
   – Manufacturing process
   – Facility layout, cleanrooms & utilities
   – Target domestic & export markets

   Our Experience in Chennai Pharma & Biotech Cluster

   • 3000+ BMRs prepared and reviewed
   • Operational since 2008
   • Extensive experience with Chennai, Sriperumbudur, Oragadam, Ambattur, Guindy, Chengalpattu clusters
   • Exposure across regulated global markets

   Product Categories Covered
   • Finished dosage forms
   • APIs & intermediates
   • Sterile injectables
   • Biologics & vaccines
   • Biosimilars
   • Nutraceuticals & herbal 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 Chennai

   • Pharmaceuticals & APIs
   • Biotech, biologics & vaccines
   • Contract manufacturing (CMOs/CDMOs)
   • Nutraceutical & herbal manufacturers
   • Cosmetics & personal care
   • Export-oriented manufacturing units

   Why Chennai Manufacturers Choose BMRx

   • 🧬 Strong understanding of pharma, API & biologics manufacturing realities
   • 🌍 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 Chennai manufacturers for India and global regulatory success.
   (PK modeling, QC verification, BE statistics)

6. Documentation & Submission
   (CSR, CDP report, validation package & CTD modules)

Who We Support in Chennai

• Pharmaceutical manufacturers (R&D & commercial)
• Biotech companies & innovation labs
• CROs & clinical trial units
• Export-oriented formulation companies
• Start-ups entering regulated markets