Uniquely qualified

Uniquely qualified

to meet complex regulatory requirements across any therapeutic area or product line

Our Regulatory Affairs team manages all the steps necessary to obtain and maintain marketing authorization for our partners’ products. The team has extensive experience with an array of products, including biological and chemical products, generics, medical-devices, pharmaceutical like products, food supplements, and live cells.

We actively foster healthy multilateral relationships among our partners, our team, and regulators. This makes us uniquely qualified to meet complex regulatory requirements across any therapeutic area or product line.

In an advisory role, we offer insights on the current regulatory climate and changes that could affect proposed activities.

DDU Brings

We can respond quickly to changes in strategy, demand, or regulations. Our regulatory program is dynamic and constantly updated to meet the challenges of an evolving regulatory environment.
Being part of the Algorithm Group, we can offer unparalleled regulatory market capabilities, backed by expertise in Middle East and North Africa markets.
In close collaboration with our Quality and Supply Chain teams, as well as external partners, we work around the clock to guarantee the integrity of each shipment received at our warehouses.
We complement this broad expertise with a tailored approach to each product and each strategic decision.

Services Provided by Our Regulatory Affairs Team

Our registration strategies are designed around individual product and patient needs. We provide end-to-end supervision for each step of the dossier-registration process. We also provide support and strategic guidance to navigate the shifting regulatory requirements.

Our collaborative, cross-departmental model ensures prompt registration. We have a proven track record of enabling patient early access to many life-saving and innovative products.

In line with our dossier-management strategy, throughout the life cycle of the product, our team files updates with the Ministry of Health related to changes to a product's label, indications, manufacturing site, marketing authorization holder, etc.

DDU, with the support of our partners, complies and submits pricing dossier in adherence to the Lebanese Ministry of Public Health (MoPH) pricing scheme.

Our team constantly screens MoPH scheduled and unscheduled changes to pricing schemes. This careful monitoring enables us to update our partners of pending or proposed changes or exchange rate fluctuations. With this information, our partners adapt their strategies accordingly.

DDU team work closely with the proper authorities to ensure that products are included in the reimbursement list and the authorized-products formularies of all payers, including public institutions.

To secure favorable reimbursement decisions, our regulatory and market access teams work closely with our partners to develop a complete strategy and value dossier. This dossier demonstrates how a positive reimbursement decision would bring value both to patients and the payers.
 

We work closely with our partners to provide clients access to high-value products. In particular, we have long-established expertise in NPS for specialty pharmaceuticals, rare diseases, and orphan drugs. This gives patients access to the most modern and innovative treatments. Our experience with Named Patient Supply allows us to provide special-approval to not-yet registered medications to patients requiring urgent treatment, based on their physicians' prescription.

Updated guidelines, circulars, practices, are received and shared on timely basis with our partners along with comprehensive interpretation and impact analysis. Attendance and active participation in relevant regulatory forums and conferences in Lebanon and the region which are organized or under the patronage of the Health Authorities.
We ensure the authorities are informed about the most-up-to-date safety reports, safety information related to product labeling, ADRs, and aware about the RMPs & RMMs where applicable.