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Regulatory & Medical Affairs

Finding Quality in Every Turn

Our team of experts understands your regulatory needs and provides you with tailored solutions to ensure business success in the MENA arena. We have extensive experience in regulatory filings for pharmaceuticals, medical devices, cosmetics, dietary supplements, food products, and more. From regulatory strategy development to product registration, regulatory intelligence, and post-market surveillance services, AcedrA can help you navigate the regulatory landscape of the Middle East and North Africa region with ease. Our regulatory and medical affairs specialists are committed to providing superior service and support throughout your regulatory journey in MENA. With our extensive knowledge, expertise, and experience, AcedrA is the ideal partner for regulatory affairs and medical affairs in the MENA region. Let us help you meet regulatory requirements with confidence. Contact us today to learn more about our regulatory services.

Regulatory Affairs

Get to Know our Regulatory Capabilities

At AcedrA, regulatory affairs are more than just regulatory compliance. It’s about driving business success and helping our clients unlock their potential in the Middle East and North Africa region. With our regulatory services, you can count on us to provide the guidance and support you need to stay compliant with local regulatory requirements and access untapped markets in the Middle East and North Africa region.

Get to Know our Medical Capabilities

At AcedrA, we provide a range of services tailored to your needs in Medical Affairs, from strategic planning and data analytics to operational support. We also offer training and development solutions so that medical affairs professionals can stay up-to-date on the latest trends in the sector. The MENA region is home to some of the world’s most advanced healthcare systems, so it’s no surprise that our medical expertise is in high demand.

Medical Affairs

The Compendium of Services

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Registration

With a comprehensive knowledge of the MENA region's regulatory landscape, AcedrA can successfully register any health products in the market. Our experienced team is dedicated to delivering industry-leading services and providing you with tailored registration solutions for your product.

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Variation

AcedrA's variation management suite provides complete control over the registration lifecycle of a pharmaceutical product. We enable real-time monitoring of post-approval registrations to ensure regulatory compliance and quality assurance in all jurisdictions. 

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Assessment

Our experts provide analytical services to critically review the dossier & ensure that it contains all required information as per applicable regulations. We can help you understand how best to structure your documentation, and identify potential gaps and inconsistencies in order to facilitate a successful product registration process.

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Inspection

AcedrA is designed to make the inspection process smoother and faster with a streamlined workflow. From creating the initial request to scheduling inspections, all information is tracked in an audit trail for complete traceability. Automated notifications alert stakeholders when activities are due or behind schedule, ensuring that processes stay on track.

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Audit

AcedrA’s audit services are designed to ensure the highest levels of compliance and accuracy when it comes to pharmaceuticals and warehouses. Our team is comprised of experienced professionals who are knowledgeable in relevant regulatory requirements, as well as best practices for warehouse operations.

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Compliance

AcedrA's compliance services ensure that businesses comply with relevant regulations and laws. Our experienced team of regulatory experts works with clients to create a tailored plan that meets their specific needs. We understand the complexities of compliance and are here to assist in navigating through them.

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Quality

AcedrA has a Quality Management System specifically designed for the pharma and medical industries. Our platform ensures compliant, efficient, and cost-effective management of quality control processes. It provides complete traceability & visibility over your products and processes.

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QPPV

Our QPPV (Qualified Person Responsible for Pharmacovigilance) ensures that all related PV are conducted according to the applicable local and regional regulations.

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Design

AcedrA's Regulatory Writing Services ensure that all of the necessary documents adhere to the standards set by the regulatory authorities. Our experienced professionals have a deep knowledge of regulations and requirements related to clinical trial applications, product registration dossiers, and other submissions.

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Clinical

AcedrA provides clinical services to organizations through its professional network of contract research organizations (CROs). Our partners have extensive clinical experience, including protocol development & execution, quality assurance, data management, biostatistics, medical monitoring, and regulatory affairs.

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MSL

Having a team of experienced MSLs gives AcedrA an edge in the market. Our Medical Science Liaisons have years of experience, with specialized backgrounds in various therapeutic areas and keen insights into scientific conversations.

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Information

AcedrA is designed to provide tailored medical information, depending on whether you are a healthcare professional or a patient. Whether you're looking for disease symptoms, diagnosis, treatments, and more - our platform can quickly and accurately provide the most relevant information specific to your situation.

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Training

AcedrA provides medical training courses and programs that are designed to help medical professionals enhance their skills and knowledge in the field.

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Connection

AcedrA utilizes its extensive network of highly experienced professionals in the regulatory and medical fields to guarantee that its processes are conducted to the highest standards. Through this network, AcedrA is able to connect the dots and ensure that all aspects of the regulatory and medical process are properly taken care of.

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Market Access

AcedrA is a market access solutions provider that helps businesses gain access to new markets. Our market access services are tailored to each individual company’s needs and will guide them through the process of understanding and entering different markets.

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