Expert services in Define.xml development

Maha Tech is an emerging leader in regulatory data submission and clinical programming services, focused on supporting small and mid-sized pharmaceutical, biotech, and CRO organizations. Founded with the mission to simplify and strengthen the regulatory submission process, we bring deep domain expertise, advanced tools, and personalized support to help our clients confidently navigate the path to regulatory approval.

We specialize in Define.xml generation, Pinnacle 21 validation, eCRT package development, and regulatory compliance support for global submissions—including FDA, PMDA, EMA, and NMPA.

At Maha Tech, we act as a trusted extension of your team, helping you reduce costs, avoid delays, and ensure your clinical data is presented with clarity, accuracy, and compliance. Our scalable solutions and agile approach allow us to meet tight timelines without compromising quality.

Regulatory submissions are high-stakes. One misstep can lead to costly delays, missed deadlines, and increased pressure from investors and leadership. You’re at the finish line—let us help you cross it with confidence.

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A computer screen displays a web browser with several tabs open. The browser window shows the website 'remotar.com.br', focusing on job opportunities. The interface includes standard browser elements like back and forward arrows, a refresh button, and navigation tabs.
Expert Recruitment Services
Our Vision

To become a go-to partner for regulatory submission support by empowering companies with transparent, compliant, and reliable submission solutions.

To simplify complex regulatory processes through expert consulting, automation, and cross-functional collaboration—enabling our clients to focus on delivering safe and effective therapies to the world.

Our Mission

Our Projects

Specializing in IT staffing and consulting for various industries.

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A group of young people in formal attire, predominantly white shirts and ties, gathered indoors with some holding brochures or documents. They are smiling and appear to be posing for a group photo. The background is a busy, well-lit room with tables, chairs, and people engaged in various activities, possibly a conference or fair.
Engineering Solutions

Expert recruitment for engineering and technology sectors delivered efficiently.

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A group of six professionally dressed individuals are posed together in an office setting. Three women and three men are standing and sitting, smiling towards the camera. The background features a flat-screen monitor and a table with a lamp and decorative items.
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A spacious lobby area with polished floors and a row of modern turnstiles leading to a corridor. On the right, a long black marble reception desk with several people sitting and working. Glass walls and indoor plants enhance the open and bright atmosphere.
Four people are sitting around a conference table, laughing and engaging in conversation. There are various photographs spread out on the table. The setting appears casual and creative, with soundproofing panels on the wall in a light-filled room.
Four people are sitting around a conference table, laughing and engaging in conversation. There are various photographs spread out on the table. The setting appears casual and creative, with soundproofing panels on the wall in a light-filled room.
Clinical SAS

Providing top talent for clinical SAS and biotech projects.

Explore

The staffing and consulting team provided exceptional support in finding the right talent for our IT projects. Their expertise made a significant difference in our hiring process.

Tech Solutions

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Three people are in a meeting room. One person is standing and pointing to a whiteboard filled with diagrams and flowcharts, while the other two are seated at a table with laptops and notebooks. The atmosphere appears focused and collaborative.

★★★★★

Solutions

Clinical Submission Excellence: Global Compliance, Expertise & Precision, Accelerated Timelines, Collaborative Approach

Partners

Connect

mahatechsol@gmail.com

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