Analytical Method Validation Services – Ahmedabad (India)
CDSCO-Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides end-to-end Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling, serving pharmaceutical companies in Ahmedabad, Gujarat — one of India’s largest pharma and CRO hubs.
All studies comply with:
CDSCO (Central Drugs Standard Control Organization)
ICMR & ICH GCP Guidelines
WHO TRS
New Drugs & Clinical Trials Rules (NDCTR), 2019
GLP-compliant analytical requirements
Our services support regulatory submissions for India (CDSCO/DCGI) as well as global markets.
💊 Core BA/BE Services for Ahmedabad-Based Pharma Companies & CROs
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose & multiple-dose studies; crossover/parallel designs.
• Volunteer Recruitment: Healthy volunteers or patient studies as per protocol needs.
• Ethics Approval: IEC approval from registered Ethics Committees in Ahmedabad.
• Protocol Development: Aligned with CDSCO, ICH E6 (R2), and WHO TRS guidelines.
Comparative Dissolution Profiling (CDP)
• Regulatory Need: Mandatory for CDSCO submissions (Form 44, generic approvals, FDC filings).
• Dissolution Media: Biorelevant & pharmacopoeial media.
• Similarity Factor: f2 analysis for comparing test vs. reference dissolution profiles.
• Evaluation Models: Model-independent & model-dependent dissolution comparisons.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared following CDSCO/ICH Q6A & WHO TRS guidelines.
• IVIVC Modeling: Level A, B, and C correlation.
• Predictive Tools: Pharmacokinetic prediction & dissolution-PK mapping.
Analytical Method Development & Validation
• Platforms: LC-MS/MS, HPLC-UV, and stability-indicating methods.
• Validation: As per ICH M10 and CDSCO bioanalytical method validation norms.
• Stability Studies: API & formulation stability assessment per Indian guidelines.
Pharmacokinetic (PK) Analysis
• NCA Analysis: Non-compartmental PK evaluation using validated software.
• BE Statistics: 90% CI compliance for BE acceptance criteria.
• Study Design Optimization: Power analysis & sample-size justification.
📑 CDSCO-Compliant Documentation – Tailored for Ahmedabad Submissions
We prepare complete regulatory packages for India-specific filings:
• Clinical Study Protocol
• Informed Consent Forms (ICF)
• Investigator Brochure
• Clinical Study Report (CSR) aligned with CDSCO
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules for DCGI submissions (Form 44)
✨ Why Choose BioEquiGlobal for Ahmedabad?
• Strategic Location: Supporting Ahmedabad’s growing pharma ecosystem (API manufacturers, formulation units, CROs).
• Regulatory Expertise: Deep understanding of CDSCO & NDCTR, 2019 compliance.
• Quality-Focused Operations: GCP, GLP, ICH-aligned SOPs and internal QA audit systems.
• State-of-the-Art Infrastructure: Access to NABL-certified labs, validated bioanalytical platforms, and accredited clinical units.
• Global Reach: Expertise in dossiers for USFDA, EMA, MHRA, TGA, COFEPRIS, Health Canada, and others.
🗺️ Our BA/BE Workflow for Ahmedabad-Based Sponsors
Feasibility & Regulatory Assessment
(Reference product availability, CDSCO gap analysis, biowaiver eligibility)Protocol Development & Ethics Submission
(IEC approval from Ahmedabad-based Ethics Committees)Analytical Method Development
(LC-MS/MS/HPLC validation per ICH M10)Clinical Study Execution
(Volunteer recruitment, dosing, sampling, monitoring, safety management)Bioanalysis & PK/Statistical Evaluation
(PK modeling and BE assessment)CDSCO-Ready Documentation
(CSR, CDP, validation reports & CTD modules)
Who We Support in Ahmedabad
• Generic formulation manufacturers
• CROs and bioanalytical labs
• Pharmaceutical R&D & regulatory teams
• Export-oriented formulation & API companies
• Start-ups entering regulated marketsEnsuring Accuracy. Compliance. Regulatory Confidence for Ahmedabad-Based Pharmaceutical 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, and exporters based in Ahmedabad and across Gujarat with CDSCO-compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of DCGI / CDSCO queries for manufacturing licenses, product approvals, and export registrations.
Our Core Expertise – Ahmedabad Focus
VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by CDSCO, DCGI, Gujarat FDCA, and the Indian Pharmacopoeia (IP).
✅ Assay Method Validation
• Potency and content determination
• Validation as per ICH Q2 (R1 / R2) accepted by CDSCO / DCGI
• Accuracy, precision, linearity, robustness, and specificity
• IP / USP / BP / EP harmonized analytical methods
✅ Impurities Method Validation
• Related substances and degradation product profiling
• Identification 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 & modified-release formulations
• Discriminatory dissolution method development
• Media selection, sink condition evaluation, and robustness
• 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 – Ahmedabad
✅ Active Pharmaceutical Ingredients (APIs)
✅ Oral solid dosage forms (tablets, capsules, sachets)
✅ Injectable formulations (sterile & non-sterile)
✅ Semi-solid & liquid dosage forms
✅ Modified-release & controlled-release products
Regulatory Compliance – Ahmedabad (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 – Ahmedabad
VALIDEX provides complete regulatory query management, including:
✅ Responses to CDSCO / DCGI deficiency letters
✅ Scientific justification for validation parameters
✅ Data gap assessment & corrective documentation
✅ Revised validation protocols and reports
✅ Technical support during regulatory inspections & audits
Why Choose VALIDEX in Ahmedabad?
✔ Strong understanding of Ahmedabad & Gujarat pharma regulatory expectations
✔ ICH-aligned, CDSCO-focused documentation
✔ Inspection-ready and audit-compliant validation reports
✔ Fast turnaround timelines for domestic & export needs
✔ Strict confidentiality & data integrity
✔ Single-window scientific and regulatory support under Zoesoe Exports Pvt Ltd
Our Deliverables – Ahmedabad
• 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 Ahmedabad
• Pharmaceutical manufacturing companies
• API manufacturers
• Generic formulation companies
• Contract Manufacturing Organizations (CMOs)
• Export-oriented pharma units
• Regulatory & dossier consulting firms
Domestic & Export Support – Ahmedabad
VALIDEX supports Analytical Method Validation for:
• CDSCO / DCGI domestic approvals
• Gujarat FDCA manufacturing licenses
• Export dossiers prepared in Ahmedabad for US FDA, EU, WHO, LATAM, Africa & ASEAN markets
Partner with VALIDEX – Ahmedabad
Achieve CDSCO-ready analytical validation with confidence.
From method validation to regulatory approvals, VALIDEX is your trusted scientific and regulatory partner in Ahmedabad.