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Customized aRMM for National PV Center in Saudi Arabia

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Customer Requirement: A pharmaceutical company specializing in generic products, based in Saudi Arabia, required a customized additional risk minimization measure (aRMM) for its generic version of Pomaliomide capsules. This was a requirement of the regulatory agency, the Saudi Food and Drug Authority, in order to maintain safety and regulatory compliance. Problem Statement: The National Pharmacovigilance […]

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Development of Pharmacovigilance Training Modules for US-based Educational Institute

All Category, Case Studies, Pharmacovigilance /

Customer Requirement: A USA-based educational institute specializing in providing training courses to its subscribers was looking to develop a course on pharmacovigilance. This course would be the first of its kind for the educational institute and would aim to provide a robust foundational knowledge base of pharmacovigilance, including key activities, processes, and the regulations surrounding

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Drug-device registration in CIS countries

All Category, Case Studies, Regulatory /

Customer Requirement: A global Non-profit organization in the area of female health & wellness wanted to obtain drug device registration and market authorization for their contraceptive that included its administration device, in CIS region, including Azerbaijan, Kyrgyzstan and Tajikistan.  The contraceptive was classified as a drug-device combination product for which regulations are challenging to navigate

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Accelerating access to Women’s Health products

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Customer Requirement: Women’s health and fertility are vital aspects of their overall well-being, and yet they often remain shrouded in silence and misconception. Every woman has the right to access healthcare, irrespective of their socioeconomic background or geographical location, though many women face significant challenges and barriers that restricts their access to the medications they

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Web-based Lifecycle Management Tool

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Customer Requirement: A Non-profit organization faced challenges in tracking and monitoring the registration status of their products in respective regions. This is because they had one product  in multiple markets that were each in different stages of their lifecycle. Siloed and disconnected tracking systems meant that the organization was left with little insight into the

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regulatory publishing

Incorporating plug in tools to facilitate regulatory publishing tasks

All Category, Case Studies, Publishing /

Single bookmarking and hyperlinking tasks were conducted manually by regulatory publishing team members at DDReg which was a repetitive and time-consuming task. The key objective was to implement tools that would automate repetitive tasks to create a more efficient workflow for filing and e-functionality within the organization The regulatory publishing team at DDReg conducted deep

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Gulf Health Council file upload

Gulf Health Council file upload for biosimilar product

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One of the top three biopharmaceutical companies approached DDReg to get the dossiers for their product submitted to the Gulf Health Council (GHC). The challenge was to publish and submit the large size files to the GHC portal (Taawon) while running against the time. As the team finished the grueling job of publishing the sections

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Indian Herbal Pain Patch in the USA

Introduction of Indian Herbal Pain Patch in the USA

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Manufacturer of a very popular Menstrual Pain Patch with herbal ingredients wanted to introduce the product in USA. The product had herbal constituents sourced from India. With very strict US FDA requirements for importing and selling medicinal products in USA, the company wanted to have the right regulatory strategy, as the business opportunity was big.

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