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. […]
Biosimilars uptake – An upward trend Read More »
The European Union has seen some major changes and advances in Regulatory & Healthcare Policies and strategies- a key one being the “Regulatory Science to 2025” strategy to enhance EMA’s engagement with regulatory science. The need for proactive participation in such initiatives is important to support the strengthening of regulatory systems and facilitate innovation in
DDReg Exhibits at DIA Europe 2023 in Basel, Switzerland Read More »
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
Combination products: a regulatory perspective Read More »
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
Pre-market pathways for combination products Read More »
The onset of the pandemic amplified an already growing concern in the European Union (EU)- the shortage of medicines, equipment, and devices that subsequently burdens the health system and puts patients at risk. Some of the reasons for these kinds of shortages are related to problems in manufacturing that can delay production, shortages of raw
Mitigating medical device shortages in public health emergencies Read More »
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).
Access to Orphan Drugs in Hereditary Angioedema Read More »
Technology is rapidly driving the growth of the Pharmaceutical and Life Sciences industries. With digital solutions being made more easily available, drug development & pharmacovigilance are transforming to become more efficient, compliant, and patient safety focused. However, regulatory affairs is still somewhat manual where processes and tasks are repetitive, siloed, and resource-heavy. Though Life Sciences
Digitalization in Regulatory Affairs Read More »
Overview Medical Device manufacturers must demonstrate the safety, efficacy, and quality, of the product and that it functions as intended without endangering the user or patient. The European Medicines Agency (EMA) mandated a clinical evaluation report (CER) that is required to obtain a CE marking for devices that are to be marketed within the European
Medical Devices – Considerations for preparing a Clinical Evaluation Report (CER) Read More »
The European regulatory system constitutes a network of pharmaceutical regulators from the European Economic Area (EEA), the European Medicines Agency (EMA), and the European Commission (EC). In addition to ensure that patients have timely access to safe, efficacious and high quality medicines, it is responsible for establishing a regulatory environment that keeps up with innovation.
EU regulatory strategic goals for human medicines Read More »
We are exhibiting at DIA Europe 2023 Meet our experts at booth #59 to discuss your queries on market access strategies , Regulatory Intelligence, Regulatory Strategies, Feasibility Studies, Life Cycle Management. Run your regulatory processes with our technology enabled platforms that help generate better data, for faster market access, safety and efficacy of vital, life-altering
We are exhibiting at DIA Europe 2023 Read More »
