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 need for …
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 product status …
The pharmaceutical industry including its operations and associated functions run on data and content. Whether it is safety, regulatory, or clinical data, the pharmaceutical industry and all its stakeholders are actively involved in collecting, monitoring, evaluating, and exchanging crucial information. Indeed, the need for standardization of medicinal product information was highlighted in order to facilitate …
Maintaining compliance with Identification of Medicinal Products (IDMP) standards Read More »
The development of biologic products has increased over the last few years in order to treat complex and serious conditions. These biologics, or innovator products, are approaching the end of their exclusivity period which warrants for the development of biosimilars to support timely access to alternative and more affordable treatment options for patients in need. …
Combination products are an integral part of healthcare as they provide innovative treatment options for complex diseases. They can be as simple as a first aid kit with vials & syringes or as complex as antibody-drug conjugates combined with drugs [1]. More often the development of combination products helps to enhance the function of an …
The regulatory landscape for combination products has been somewhat of a “question-mark” for manufacturers for various reasons. This is because when drugs, devices, and/or biologics get combined to produce a combination product, there is uncertainty on which regulatory requirements will apply to the components of the product and the product as a whole. Furthermore, the …
IntroductionHereditary angioedema (HAE) is considered a rare, autosomal dominant disease that is characterized by repeated episodes of swelling which can occur on the face, limbs and even the gastrointestinal and respiratory tracts leading to severe pain, vomiting, and asphyxiation. These swelling attacks may occur unexpectedly and can significantly affect a patient’s quality of life (QoL). …
Single bookmarking and hyperlinking tasks were conducted manually by 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 organizationThe publishing team at DDReg conducted deep research to find …
Incorporating plug in tools to facilitate publishing tasks Read More »
A U.S.-based manufacturer had deficiencies in their abbreviated new drug application (ANDA) as it caused the U.S. FDA to Refuse to Receive (RTR) the ANDA. If additional material was submitted to correct the deficiencies, then the amended ANDA is considered a new ANDA submission and is subjected to pay a new ANDA fee. The manufacturer …
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 of …
Gulf Health Council file upload for biosimilar product Read More »
