Analytical Development

Precision Meets Innovation in Analytical Science
At Servona Tech, we deliver comprehensive analytical development solutions tailored to meet the evolving needs of the pharmaceutical industry. Our team ensures scientific excellence and regulatory compliance at every stage of your project.

📄 Introduction:

Our Analytical Development division is dedicated to supporting pharmaceutical projects from early-stage method development to full-scale validation and stability testing. With a strong focus on cGMP compliance , we provide accurate, reproducible, and robust analytical methods that support drug substance and product lifecycle management.

Whether you’re developing a new compound or preparing for regulatory submission, our experts are committed to delivering results that meet global standards.

✅ Key Services:

1. Analytical Method Development

We develop scientifically sound and robust analytical methods tailored to your specific drug substances and products. This includes related substances, assay, dissolution, and impurity profiling methods.

2. Raw Material Analysis

Comprehensive testing of raw materials and excipients to ensure quality, purity, and compliance with pharmacopoeial standards (USP, EP, BP, JP).

3. Analytical Method Validation

Full validation of analytical procedures according to ICH Q2(R1) guidelines, covering accuracy, precision, specificity, linearity, range, detection limit, quantitation limit, and robustness.

4. Preparation of Regulatory Submissions (e.g., NODCAR Files)

We assist in compiling and reviewing analytical sections of regulatory dossiers, ensuring alignment with local and international requirements for submissions to health authorities.

5. Stability Testing

Conducting stability studies in accordance with current ICH guidelines , including real-time, accelerated, and stress testing under controlled conditions to assess product shelf life and integrity.

🎯 Why Choose Servona Tech?

• Scientific Expertise: Our team consists of highly qualified scientists with extensive experience in analytical chemistry.
• Regulatory Compliance: All activities follow cGMP, GLP, and ICH standards.
• Advanced Facilities: State-of-the-art laboratories equipped with modern analytical instrumentation.
• Client-Centric Approach: We offer customized solutions designed to meet your project timelines and specifications.

💬 Ready to Get Started?

Let us help you bring your pharmaceutical product to market with confidence.
👉 Contact Us today to discuss your analytical development needs.

Servona Tech
📞 Phone: +201009076870
📧 Email: [email protected]
📍 Address: 393 Building – 5th District – 6th City of October, Giza, Egypt