Solutions

Market Access

Are you applying for a MDMA with the SFDA? Need assistance with clinical trial registration in the UAE? Seeking guidance for medical device registration in Egypt? Or perhaps you’re Generally planning to expand your business in the MENA region and need support? Regardless of your specific needs, we can provide assistance with any of these.

Contact Registitute today to thrive your business in MENA region.

Regularity & Quality

Quality Management System

QMS/ISO Certification

We pride ourselves on staying abreast of regulatory requirements and industry best practices, ensuring that your QMS is robust and effective. We assist in identifying QMS gaps at any stage, support with audits, and offer digital transformation solutions. Learn More

Technical Assistance

Streamline Your Documents compilation with our proven approach - Effortlessly avoide trial-and-error and ensure that the process is optimized from the start. Learn More

Clinical Research

Are you looking to bring innovative or generic products to market? The field of clinical research is critical in ensuring the safety and efficacy of your products, but navigating regulatory requirements and expectations can be a daunting task. That's where we come in. Learn More

Operations

Power up your business with our tailored Back-Office Services, Including Regulatory Intelligence Reports, Training, Translation, and Digital Tools. Learn More

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Our back-office services are designed to elevate the level of care that healthcare providers offer their patients. We specialize in providing comprehensive solutions that support healthcare professionals in managing their operations and achieving optimal outcomes.

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One of our specialized services includes expert translation services for a range of healthcare documents. We provide accurate and culturally appropriate translations for patient records, consent forms, certificates and clinical trial materials.

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In addition to our translation services, we offer customized training programs that help healthcare professionals stay up-to-date with the latest industry trends and regulations. Our programs include compliance training, clinical training, and leadership development.

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We also offer a range of digital tools designed to automate processes, improve communication, and track performance metrics. Our tools include patient portals, electronic medical record (EMR) systems, and Telehealth solutions.

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Our licensing support services help healthcare professionals navigate the complex licensing process, ensuring they remain in compliance with all regulatory requirements.

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We offer support services that include assistance with credentialing, licensure applications, and renewals.

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Furthermore, we provide healthcare recruitment services to find qualified candidates for a range of positions, from clinical roles to administrative staff. This service is provided on a smaller scale, usually in conjunction with another project.

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Along with our specialized services, we offer comprehensive back-office solutions that can help healthcare providers manage their finances, HR functions, and IT needs.

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In summary, our tailored services for healthcare professionals and health institutions can help optimize operations and provide the best possible care for patients. Please contact us today to learn more about how we can assist you in achieving your goals.

Kick -off

We appreciate that every project has a unique narrative. Within the initial consultation, we actively engage with our clients to grasp the full extent of their ambitions and challenges. We draw on our extensive expertise and insights garnered from similar engagements to provide an informed and tailored perspective.

Upon completing the Kick-off checklist, we will embark on a comprehensive and rigorous gap analysis of the client's product, quality management system, and financial plan.

Market Readiness

In this phase, we will present to you a minimum viable plan for your project, which may include, but is not limited to, the following components: defining your product group and/or class, regulatory strategy, required submission documents, statistical analysis, in-country representation mandates, distribution models, pricing and reimbursement/launch sequence, and clinical development pathway. We warmly welcome you to review the information regarding approval for clinical trials in the United Arab Emirates.

Take-off

Our plan is contingent upon your approval, and we will not proceed until we receive it.

Upon choosing to utilize our services, we will initiate your project by taking the necessary steps, which include supporting you in compiling necessary documents such as TDs, CTDs, eCTDs, verifying the required submission documents, securing a local representative and distribution channels.

We will perform label check, and provide proofreading and translation services, as needed.

Finally, we will conduct a apre-submission review to acknowledge the submission readiness.

Regulatory Approval

In order to get your product approved, we will submit the application to the designated health authority. From that juncture forward, we will handle all inquiries and address any questions that may arise during the review process, thereby expediting your approval.

We cordially invite you to peruse the details of our innovative approach to medical device registration in Saudi Arabia

Business Development

Upon approval of your product, our team stands ready to provide comprehensive support in implementing your marketing plan and positioning your product for optimal sales.

We specialize in helping clients achieve and exceed their sales forecasts through expert guidance on strategy, tactics, and execution.

Moreover, if desired, we can conduct in-depth market research to analyze your competitors' market share and recent activities, allowing you to make more informed decisions about your own marketing approach.

Life cycle management

Entrust us with the responsibility of handling your post-marketing activities, we can help you avoid the time-consuming process of periodic searches, costly setups, and business risks. By taking care of these tasks ourselves, we can ensure that your product remains compliant throughout its lifecycle.