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 »
Worldwide In-Market compliance A UK based company with manufacturing locations around the globe and a large consumer healthcare portfolio required in-market compliance check for its products all across the globe. The brands were very popular and could not afford to go off the shelf due to non-compliance should an agency inspection happen. DDReg was tasked …
Introduction of Indian Herbal Pain Patch in the USA 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 …
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POM to P & GSL Switch – First Time for Molecule One of the top Indian multinational companies has been selling an antihistamine in the UK as Prescription Only Medicine (POM). DDReg was assigned with the task to assess the feasibility of change in the legal status of the product and thereafter support the regulatory …
Development of all inclusive “Global” DMF Agencies across the emerging markets have been dealing with lot of ambiguities pertaining to Active Substance. These ambiguities emanate when a number of applicants submit diverse active substance information or Drug Master files (DMFs) on the same active by the same Active supplier (DMF Source). This usually happens when …
Biosimilar Market Authorization in Malaysia Unlike most small-molecule drugs, which are chemically synthesized with highly predictable structures and functions, biologics and biosimilars are pharmaceutical compounds synthesized or extracted from a biological source, often with much more complex structures. Thus, unlike generic medicines in which the active ingredients are identical to the reference small-molecule drug, biosimilars …
