Welcome to Technical Tools

Your Gateway to Technical Excellence! Empowering pharmaceutical companies with smarter, faster, and more efficient ANDA submission tools.

Streamline your ANDA submission process with iTechnical Tools' comprehensive suite of Technical Tools, designed to address every aspect of the FDA’s rigorous requirements. From initial development to final submission, our innovative platform ensures compliance, enhances efficiency, and minimizes risks, empowering pharmaceutical companies to achieve faster approvals with fewer deficiencies.

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Explore Our Comprehensive Suite of Tools
1. ANDA Review Checklists
Ensure complete and accurate submissions across multiple dosage forms, reducing RTR or deficiency risks.
2. Upper Management Review Checklists
Verify the completeness of submissions with specialized checklists for senior professionals.
3. White Paper (Strategic Paper) Templates
Foster strategic planning and inter-departmental collaboration for efficient submissions.
4. Controlled Correspondence Templates
Adhere to regulatory requirements with well-structured templates for common queries.
5. DMF Review Checklist
Identify gaps early and ensure compliance for seamless drug master file submissions.
6. Validation Checklist (API & FP)
Ensure method validation meets FDA and ICH guidelines to enhance submission quality.
7. ANDA Facility Template
Streamline facility inspection readiness by capturing all required data for FDA approval.
8. API Facility Template
Simplify data collection for API testing and manufacturing facilities.
9. IIG Evaluation Checklist
Evaluate inactive ingredient database compliance to prevent RTR concerns.
10. Size, Shape & Score Checklist
Guarantee consistency in drug design for patient safety and regulatory acceptance.
Key Benefits of iTechnical Tools
Compliance Assurance

Aligned with FDA guidance to reduce deficiencies.

Efficiency Gains

Streamlined processes from product inception to filing.

Risk Mitigation

Early identification of potential gaps or errors.      

Accelerated Approvals

Faster time-to-market with fewer review cycles.     

Why iTechnical Tools ?
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Expert-Driven Insights

Tools built by regulatory experts with 3 decades of Experience.

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Efficiency Redefined

Save time & avoid Costly Errors using different innovative tools.

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Comprehensive Coverage

Helps to achieve faster approval & avoid compliance risk.

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Organizational Advantages

Helps to achieve faster approval & avoid compliance risk

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System Driven Approach

Allows user to follow step by step process with through review.

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Real Time Updates

Submission meets the latest standards & current expectations of Authority.