Regulatory support

Nowadays, out-sourcing is a very effective solution. Many Healthcare companies whether pharmaceutical or Medical device companies are outsourcing their Regulatory Affairs function when it comes to the Middle East and Africa region. Not only does this ensure smooth operations but it can also mean less risk and less costs.

After the expenditure and effort of product development, it is essential to ensure that you get the best out of your investment. MERAS services span the entire lifecycle of a drug, from pre-clinical rphase tto post marketing and cover all regulated areas: Drug Development, Regulatory Affairs, Pharmacovigilance and Market Access.

We support companies by developing innovative and cost-effective development and regulatory strategies and solutions, tailored to the client, to achieve set milestones and thereby optimize regulatory approval and market access.

Our regulatory support services are provided by a highly experienced team who stay updated of the most recent developments in their field.

As a client-driven company, our services are flexible enough to be used for a complete outsourcing package (Regulatory affairs/Pharmacovigilance/Life Cycle Management/Market Access) or as just stand-alone services.

The field of regulatory affairs encompasses all the work that is necessary to receive and maintain a marketing authorisation or registration for a medicinal product. Dossiers are at the forefront of this process. We can prepare the dossier, publish in the right format and manage the procedure from submission to close-out and our experts can assist you with the preparation of responses to questions raised by the regulatory agency. Once registration is complete, we can support you with ongoing maintenance for the registration dossier. We can also review existing dossiers for gaps and regulatory compliance

Face to Face Meetings with regulatory agencies can be very useful. Our team can guide you through the entire process, from making the meeting arrangements and preparing the list of questions with briefing information.

For medicines, our experts will advise on all aspects of drug development and our regulatory strategy services. It is vital to get organised and prepare target SmPCs, orphan drug applications and paediatric investigation plans, and evaluate the potential impact of your product on the environment (via an environmental risk assessment), well in advance of marketing authorisation applications. Our team is ready to prepare these for you with the application of their significant regulatory knowledge and experience, to guide you through the regulatory maze.

Our regulatory experts can assist with changes in legal status for your prescription medicine portfolio. Our experts will liaise with relevant regulatory authorities, healthcare professional and consumer-patient organisations to determine current opinion and assist in the development of the regulatory affairs strategy. We will also prepare the registration package and manage the regulatory process.

For devices, our experts will use their deep regulatory knowledge to advise on the correct classification of and clinical evaluation strategy for your product. Their experience is used to help you comply with all the applicable regulations and standards, to prepare technical files and design and implement a fully compliant Quality Assurance Management System.

Adding to the regional procedural complexities, a handful of end-to-end Regulatory service providers make the situation even more critical for manufacturers expansion in a cost-effective way. For example, if a European based drug manufacturer is interested in marketing their product in the Middle East, they may require a service provider who has complete knowledge of the Middle East Pharma Regulatory market space along with some knowledge of a customizable suite of Regulatory services spanning across strategy to submissions, rather than a regular service provider who has expertise in only one country, and might incur huge costs for the drug manufacturer.

Enabling life sciences organizations to meet their Regulatory goals across the globe for Pharma, Generics, Biosimilars, Vaccines, Cosmetics, OTC, Nutraceuticals/Food and Dietary Supplements, and Medical Devices, Freyr offers a full spectrum of end-to-end Regulatory services that span across strategy to submissions and lifecycle maintenance.

MERAS can act as your dedicated Regulatory Affairs department covering the whole Middle East and Africa region with great experience in the regulatory requirements for the different countries.