Analytical Method Validation Services – Panaji, Goa (India)
CDSCO-Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides complete Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling to support pharmaceutical companies located across Goa, including Panaji, Verna Industrial Estate, Ponda, Kundaim, Colvale, and Tuem.
Goa is a major pharmaceutical manufacturing hub, especially for export-focused formulations — making regulatory-compliant BA/BE services essential for product approvals.
All studies are conducted following:
CDSCO (Central Drugs Standard Control Organization)
New Drugs & Clinical Trials Rules (NDCTR), 2019
ICH GCP & WHO TRS
GLP-certified analytical processes
ICMR Ethical Guidelines
We support regulatory submissions for CDSCO, as well as global agencies: USFDA, EMA, MHRA, TGA, Health Canada, GCC, SAHPRA, and more.
💊 Core BA/BE Services for Goa’s Pharma Manufacturing Cluster
Clinical BA/BE Studies (Human)
• Single-dose & multiple-dose BE studies (crossover/parallel).
• Healthy volunteer or patient-based studies depending on therapeutic class.
• IEC approval via CDSCO-registered Ethics Committees in Goa/nearby NCR hubs.
• Protocol design aligned with ICH E6 (R2), WHO TRS & CDSCO guidelines.
Comparative Dissolution Profiling (CDP)
• Required for Form 44 submissions, FDC approvals, and post-approval stability/formulation changes.
• Dissolution studies in IP/USP/EP & biorelevant media (FaSSIF/FeSSIF).
• f2 similarity factor evaluation for dissolution comparison.
• Model-dependent and model-independent dissolution assessments.
IVIVC & Biowaiver Support
• BCS-based biowaiver preparations per CDSCO, WHO TRS, and ICH Q6A guidelines.
• Level A/B/C IVIVC modeling for predictive PK correlations.
• Supports waiver of in vivo studies in applicable cases.
Analytical Method Development & Validation
• State-of-the-art LC-MS/MS & HPLC-UV platforms.
• Method validation following ICH M10 & CDSCO requirements.
• Stability-indicating methods for APIs and finished dosage forms.
Pharmacokinetic (PK) & BE Statistical Evaluation
• Non-compartmental PK analysis (NCA).
• BE evaluation using the standard 90% CI acceptance range.
• Sample-size & power calculations based on intra-subject variability.
📑 CDSCO-Compliant Documentation for Goa Submissions
We prepare complete regulatory documentation, including:
• Clinical Study Protocol
• Informed Consent Form (ICF)
• Investigator Brochure
• Clinical Study Report (CSR) as per CDSCO & ICH E3
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile (CDP) Report
• CTD/ACTD Modules (1–5) for Form 44 & international filings
✨ Why Choose BioEquiGlobal for Goa?
• Strong Presence in Goa’s Pharma Belt: Goa hosts many leading export-oriented pharmaceutical manufacturers, making BA/BE support crucial.
• Regulatory Accuracy: Expertise with NDCTR, CDSCO guidelines, and international regulatory expectations.
• Infrastructure Access: Connection with NABL-certified analytical labs and accredited clinical research facilities.
• Ideal for Export Markets: Specialized support for ANDA, CTD, eCTD submissions for highly regulated global markets.
• End-to-End Partner: From dissolution development and clinical BE to final dossier submission.
🗺️ BA/BE Study Workflow for Goa-Based Sponsors
Feasibility & CDSCO Regulatory Assessment
(Reference product selection, biowaiver evaluation, dossier planning)Protocol Development & IEC Approval
(Ethics submission through recognized committees)Analytical Method Development & Validation
(LC-MS/MS assays validated per ICH M10)Clinical BA/BE Study Execution
(GCP-compliant dosing, sampling, and safety monitoring)Bioanalysis & PK/BE Evaluation
(PK modeling, QC verification & BE statistics)Documentation & Submission
(CSR, CDP, analytical validation & CTD modules)
Who We Support in Goa
• Large-scale formulation manufacturers
• Export-oriented pharma companies (NDA/ANDA/CTD markets)
• CROs & bioanalytical laboratories
• R&D-focused pharma units
• Biotech & specialty pharma companies
• Start-ups entering global regulated marketsEnsuring Accuracy. Compliance. Regulatory Confidence for Goa-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, formulation units, API suppliers, CMOs, and export-oriented pharma companies located in Panaji, Verna Industrial Estate, Ponda, Vasco da Gama, and across Goa with CDSCO-compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of DCGI / CDSCO and Goa State Drugs Control Administration queries for manufacturing licenses, product approvals, and export registrations.
Our Core Expertise – Panaji (Goa) Focus
VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by CDSCO, DCGI, Goa State Drugs Control Administration, and the Indian Pharmacopoeia (IP).
✅ Assay Method Validation
• Potency and content determination for APIs & finished 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 – Panaji / Goa
✅ 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 – Panaji / Goa (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 – Panaji / Goa
VALIDEX provides complete regulatory query management, including:
✅ Responses to CDSCO / DCGI & Goa Drugs Control 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 Goa?
✔ Strong understanding of Goa’s formulation- and export-oriented pharma ecosystem
✔ ICH-aligned, CDSCO-focused documentation
✔ Inspection-ready and audit-compliant validation reports
✔ Fast turnaround timelines for domestic & export-driven units
✔ Strict confidentiality & data integrity
✔ Single-window scientific and regulatory support under Zoesoe Exports Pvt Ltd
Our Deliverables – Panaji / Goa
• 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 Goa
• Pharmaceutical manufacturing companies
• API manufacturers & suppliers
• Generic formulation companies
• Contract Manufacturing Organizations (CMOs)
• Export-oriented pharma units
• Regulatory & dossier consulting firms
Domestic & Global Export Support – Panaji / Goa
VALIDEX supports Analytical Method Validation for:
• CDSCO / DCGI domestic approvals
• Goa State manufacturing licenses
• Export dossiers prepared in Goa for:
US FDA | EU | UK | WHO | LATAM | Africa | ASEAN | GCC
Partner with VALIDEX – Panaji, Goa
Achieve CDSCO-ready analytical validation with confidence.
From method validation to regulatory approvals, VALIDEX is your trusted scientific and regulatory partner in Panaji and across Goa.