Analytical Method Validation Services – Chennai (India)
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
Feasibility & Regulatory Assessment
(Reference product identification, CDSCO gap review, biowaiver evaluation)Protocol Design & IEC Approval
(Ethics board approval through Chennai-based IECs)Analytical Method Development & Validation
(LC-MS/MS method development aligned with ICH M10)Clinical Study Execution
(GCP-compliant dosing, sampling, oversight, safety monitoring)Bioanalysis & PK/BE Evaluation
(PK modeling, QC verification, BE statistics)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 marketsEnsuring Accuracy. Compliance. Regulatory Confidence for Chennai-Based Pharmaceutical & API Manufacturers
VALIDEX, a scientific arm of Zoesoe Exports Pvt Ltd, provides end-to-end Analytical Method Validation (AMV) services for Active Pharmaceutical Ingredients (APIs) and Pharmaceutical Finished Products, fully compliant with Indian regulatory requirements.
We support pharmaceutical manufacturers, API units, CMOs, CROs, and export-oriented companies located in Chennai and across Tamil Nadu with CDSCO-compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of DCGI / CDSCO and Tamil Nadu Drugs Control Department queries for manufacturing licenses, product approvals, and global export registrations.
Our Core Expertise – Chennai Focus
VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by CDSCO, DCGI, Tamil Nadu Drugs Control Department (TN DCD), and the Indian Pharmacopoeia (IP).
✅ Assay Method Validation
• Potency and content determination for APIs & formulations
• Validation as per ICH Q2 (R1 / R2) aligned with CDSCO / DCGI expectations
• Accuracy, precision, linearity, range, robustness, and specificity
• IP / USP / BP / EP harmonized analytical methods
✅ Impurities Method Validation
• Related substances, degradation products, and process impurities
• Identification, qualification, and quantification of impurities
• Stability-indicating method validation as per Schedule M & IP
• Compliance with ICH Q3A / Q3B / Q3D (elemental impurities)
✅ Dissolution Method Validation
• Immediate-release, delayed-release & modified-release dosage forms
• Discriminatory dissolution method development
• Media selection, sink condition evaluation, and robustness studies
• Compliance with IP & CDSCO product approval requirements
✅ Residual Solvents Method Validation
• Gas Chromatographic (GC) method validation
• Compliance with ICH Q3C adopted by CDSCO
• Class I, II & III residual solvents
• Limits, system suitability, accuracy, precision, LOD & LOQ
Products Covered – Chennai
✅ Active Pharmaceutical Ingredients (APIs)
✅ Oral solid dosage forms (tablets, capsules, sachets)
✅ Liquid oral formulations (syrups, suspensions)
✅ Semi-solid dosage forms (ointments, creams, gels)
✅ Injectable formulations (sterile & non-sterile)
✅ Modified-release & controlled-release products
Regulatory Compliance – Chennai (India)
All Analytical Method Validation activities are conducted in accordance with:
• ICH Q2 (R1 / R2)
• CDSCO / DCGI Guidelines
• Drugs & Cosmetics Act, 1940 and Rules, 1945
• Schedule M & Schedule Y (where applicable)
• Indian Pharmacopoeia (IP)
• WHO-GMP adopted by CDSCO
Post-Submission Regulatory Support – Chennai
VALIDEX provides complete regulatory query management, including:
✅ Responses to CDSCO / DCGI & Tamil Nadu DCD deficiency letters
✅ Scientific justification for validation parameters
✅ Data gap assessment & corrective documentation
✅ Revised validation protocols and reports
✅ Technical support during GMP inspections & regulatory audits
Why Choose VALIDEX in Chennai?
✔ Strong understanding of Chennai’s API, formulation & export-driven pharma ecosystem
✔ ICH-aligned, CDSCO-focused documentation
✔ Inspection-ready and audit-compliant validation reports
✔ Fast turnaround timelines for domestic & export projects
✔ Strict confidentiality & data integrity
✔ Single-window scientific and regulatory support under Zoesoe Exports Pvt Ltd
Our Deliverables – Chennai
• India-compliant Analytical Method Validation Protocols
• Validation Reports for:
o Assay
o Impurities
o Dissolution
o Residual Solvents
• CTD / Non-CTD summaries for CDSCO submissions
• Regulatory query response packages
• Method transfer, verification & re-validation documentation
Industries We Serve in Chennai
• Pharmaceutical manufacturing companies
• API manufacturers
• Generic formulation companies
• Contract Manufacturing Organizations (CMOs)
• Contract Research Organizations (CROs)
• Export-oriented pharma units
• Regulatory & dossier consulting firms
Domestic & Global Export Support – Chennai
VALIDEX supports Analytical Method Validation for:
• CDSCO / DCGI domestic approvals
• Tamil Nadu State manufacturing licenses
• Export dossiers prepared in Chennai for:
US FDA | EU | UK | WHO | LATAM | Africa | ASEAN | GCC
Partner with VALIDEX – Chennai
Achieve CDSCO-ready analytical validation with confidence.
From method validation to regulatory approvals, VALIDEX is your trusted scientific and regulatory partner in Chennai.