📑 Regulatory Support – Professional Page Content

Ensuring Compliance, Accelerating Approvals

At Servona Tech , we understand that regulatory compliance is a critical step in bringing your pharmaceutical product to market. Our Regulatory Support services are designed to help you navigate the complex requirements of global and regional health authorities with confidence and efficiency.

From dossier preparation to submission-ready documentation, our team ensures that your project meets all scientific and regulatory standards — saving you time, reducing risk, and accelerating approval timelines.

📄 Introduction:

The regulatory landscape for pharmaceutical products is continuously evolving, requiring precise documentation, scientific accuracy, and full compliance with international guidelines.

At Servona Tech, our Regulatory Affairs experts work closely with clients to develop comprehensive regulatory strategies tailored to their specific products and target markets. Whether you’re preparing for local registration or international submissions, we provide end-to-end support to ensure your dossiers meet the highest quality standards.

✅ Key Services:

1. CTD / eCTD Dossier Preparation

We prepare complete Common Technical Document (CTD) and electronic CTD (eCTD) dossiers in accordance with ICH guidelines for submission to regulatory agencies such as the FDA, EMA, WHO, and NAFDAC.

2. Module 3 – Quality Documentation

Our team prepares high-quality Module 3 documents covering drug substance and drug product development, manufacturing processes, characterization, and analytical testing data.

3. NODCAR File Compilation

We assist in compiling and reviewing NODCAR files for submission to Egyptian Drug Authority (EDA), ensuring alignment with local regulatory requirements.

4. Regulatory Gap Assessment

We conduct thorough reviews of existing documentation to identify gaps and provide actionable recommendations for improving submission readiness.

5. DMF (Drug Master File) Preparation & Submission

We support the preparation and maintenance of DMFs for active pharmaceutical ingredients (APIs) and excipients, facilitating confidential communication with regulatory agencies.

6. Labeling & Package Insert Review

We review labeling content and package inserts to ensure compliance with regulatory requirements and accurate representation of product information.

🎯 Why Choose Servona Tech?

  • Expert Team: Our regulatory professionals have extensive experience with both local and international regulatory frameworks.
  • Compliance Focused: All submissions adhere strictly to ICH, FDA, EMA, and local authority guidelines.
  • Timely Delivery: We understand deadlines matter — our team works efficiently to ensure on-time delivery of regulatory documents.
  • Client-Oriented Approach: We tailor our support to your specific needs, whether you’re submitting for one country or multiple regions.

💬 Ready to Submit with Confidence?

Let Servona Tech be your trusted partner in navigating the regulatory process successfully.
👉 Contact Us today to discuss your regulatory support needs.

📍 Contact Information:

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