🇮🇳 Bioavailability & Bioequivalence (BA/BE) Studies Services for Roorkee

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 tailored for pharmaceutical companies operating in Roorkee, a key pharmaceutical and industrial hub in Uttarakhand.

Roorkee, along with nearby regions like Haridwar, Selaqui, and Dehradun, houses a growing number of formulation units, manufacturing plants, and R&D facilities — making BA/BE support essential for regulatory submissions.

All studies are conducted as per:

• CDSCO (Central Drugs Standard Control Organization)

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

• ICMR Ethical Guidelines

• ICH GCP & GLP

• WHO TRS

We support CDSCO/DCGI submissions and international regulatory filings for USFDA, EMA, TGA, MHRA, Health Canada, and more.

💊 Core BA/BE Services for Roorkee’s Pharma & R&D Sector

Clinical BA/BE Studies (Human)

• Single-dose & multiple-dose BE studies (crossover & parallel).
• Healthy volunteer & patient-based studies as applicable.
• IEC approval from CDSCO-registered Ethics Committees across Uttarakhand/NCR.
• Protocol development aligned with ICH E6 (R2), WHO TRS & CDSCO guidelines.

Comparative Dissolution Profiling (CDP)

• Required for Form 44 filings, generic product development, and FDC approvals.
• Testing performed in IP/USP/EP pharmacopoeial media & biorelevant media.
• f2 similarity factor for dissolution curve comparison.
• Model-independent & model-dependent analysis approaches.

IVIVC & Biowaiver Support

• BCS-based biowaivers prepared as per CDSCO, ICH Q6A, and WHO TRS.
• Level A/B/C IVIVC models for predictive in vitro–in vivo correlation.
• PK modeling for in vivo BE waiver justification.

Analytical Method Development & Validation

• LC-MS/MS & HPLC-UV analytical platforms.
• Method validation per ICH M10 & CDSCO requirements.
• Stability-indicating methods for APIs and formulated products.

Pharmacokinetic (PK) & Statistical BE Evaluation

• Non-compartmental PK analysis (NCA).
• BE statistical evaluation using 90% CI BE acceptance range.
• Power analysis & sample-size optimization for robust study outcomes.

📑 CDSCO-Compliant Documentation for Roorkee Submissions

We prepare full regulatory documentation, including:

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

✨ Why Choose BioEquiGlobal for Roorkee?

• Strategic Pharma Manufacturing Zone: Roorkee’s proximity to Haridwar & Selaqui industrial areas makes it ideal for integrated BE support.
• Regulatory Expertise: In-depth experience with CDSCO, NDCTR guidelines & international regulatory frameworks.
• Strong Research & Academic Presence: Proximity to IIT Roorkee and regional research universities enhances scientific collaboration.
• Advanced Infrastructure: Access to NABL-certified analytical labs and accredited clinical research centres.
• Export-Oriented Support: Specialized expertise in ANDA, CTD, and eCTD dossier preparation.

🗺️ BA/BE Study Workflow for Roorkee Sponsors

1. Feasibility & Regulatory Assessment
   (Reference product review, CDSCO gap analysis, biowaiver feasibility)

2. Protocol Development & IEC Approval
   (Ethics submission via Uttarakhand/NCR-based IECs)

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

4. Clinical Study Execution
   (GCP-compliant recruitment, dosing, PK sampling & safety monitoring)

5. Bioanalysis & PK/BE Evaluation
   (PK modeling, QC verification & statistical BE assessment)

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

Who We Support in Roorkee

• Formulation manufacturers & API units
• CROs & clinical research organizations
• R&D centres & pharmaceutical testing labs
• Export-focused pharma companies
• Start-ups entering regulated pharmaceutical markets