Market Access

Are you looking to expand your business into MENA region, but unsure of where to start? Our market access consultation service provides you with the expertise and guidance you need to navigate complex market regulations and maximize your chances of success.

Commencing market access successfully can be a formidable undertaking, necessitating meticulous strategizing and implementation. The below ensuing diagram presents an intricate blueprint for executing this, partitioning the procedure into explicit and manageable stages. Through adherence to this proposal, you can thrive your business in MENA region.

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, clinical development pathway, statistical analysis, in-country representation mandates, distribution model, and pricing and reimbursement/launch sequence. We warmly welcome you to review the information regarding approval for clinical trials in the United Arab Emirates.

Take-off

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 local representation and distribution channels.

Furthermore, 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.

Contact Registitute today to thrive your business in MENA region.