DDReg pharma

Quailty Driven by Passion

Submit Query

All Category

Home » All Category » Page 19

The Advancements of Gene Editing Technology for Safe and Effective Gene Therapy Products

All Category, Insights, Regulatory /

The field of gene therapy has witnessed significant advancements with the development of genome editing technologies. These technologies allow scientists to break, modify, and edit specific genes in a DNA sequence-specific manner, opening up new possibilities for gene therapy. While traditional gene therapy involves the addition of new genes to human cells or tissue, genome […]

The Advancements of Gene Editing Technology for Safe and Effective Gene Therapy Products Read More »

Customized aRMM for National PV Center in Saudi Arabia

All Category, Case Studies /

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

Customized aRMM for National PV Center in Saudi Arabia Read More »

banner_image

Increasing Harmonization for Complex Generics

All Category, Blogs /

Regulatory agencies across the globe are increasing their efforts in advancing the development of complex generics to facilitate patient and/or consumer access to safe, efficacious, and high-quality generic medicines. The generic medicine industry is already associated with many challenges such as declining profit margins and pricing making it a less attractive industry for generic pharmaceutical

Increasing Harmonization for Complex Generics Read More »

Strengthening Safety Compliance in Somalia

All Category, Blogs, Pharmacovigilance /

The National Medicine Regulatory Authority (NMRA) of the Ministry of Health regulates and controls regulatory & safety related operations for pharmaceuticals in Somalia. It is responsible for facilitating the availability and accessibility of safe and effective medicines to the Somalian population. More recently, the Somalian NMRA issued their very first Somali Pharmacovigilance Guideline with the

Strengthening Safety Compliance in Somalia Read More »

Ensuring Viral Safety of Biotechnology Products

All Category, Blogs, Medical Writing /

Biotechnology products that are derived from cell lines are associated with a certain degree or risk of viral contamination. These risks can be attributed to source cell line contaminations or exogenous introduction of adventitious virus; indeed these risks need to be reduced as contamination can have major consequences. Virus testing programs have supported in assuring

Ensuring Viral Safety of Biotechnology Products Read More »

Regulatory Roadmap for Access to MedTech

All Category, Blogs, Medical Device /

In an era driven by technological advancements, particularly in healthcare, the need to implement a robust regulatory framework is more than ever to ensure compliance and patient safety. Indeed technological disruptors such as implantable medical devices, artificial intelligence, software, and diagnostics play a crucial role in healthcare whether they facilitate early detection or prevent complex

Regulatory Roadmap for Access to MedTech Read More »

Fostering Medical Innovation with Expedited Review Processes

All Category, Blogs /

2023 marked a significant year in the pharmaceutical industry as the Center for Drug Evaluation and Research (CDER) of the US Food and Drug Administration (FDA) approved an impressive 55 novel drugs. These approvals, including new molecular entities (NMEs) and new therapeutic biologics, underscore the FDA’s commitment to advancing patient care with innovative therapies. Over

Fostering Medical Innovation with Expedited Review Processes Read More »

Easing Requirements for Minimal Risk Clinical Trials

All Category, Blogs /

Expediting clinical trials that post minimal risk is important to advance healthcare & drug development. In particular, easing the requirements for informed consent regarding trial participants- for minimal risk clinical trials- can help expedite the entire clinical development process and ultimately accelerate the overall regulatory approval process. Earlier the US FDA’s regulations allowed for exceptions

Easing Requirements for Minimal Risk Clinical Trials Read More »

Standardizing Real World Data for Drug and Biological Product Submissions

All Category, Blogs /

Real world data (RWD) is proving to be an important source of information for applications such as New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), biologic license applications (BLAs) and Investigational New Drug (IND) applications. With RWD being submitted as relevant “study data”, certain agencies like the US FDA, require that the format should

Standardizing Real World Data for Drug and Biological Product Submissions Read More »

Streamlining Clinical Investigations for Medical Devices

All Category, Blogs, Medical Device /

Clinical investigations for medicinal devices are critical in order to advance healthcare and patient safety. Streamlining clinical investigations help accelerate the delivery of innovative solutions to patients, which ensures timely access to devices that would help diagnose and treat diseases. Simplifying regulatory processes, enhancing stakeholder engagement, and aligning with global practices fosters more rapid approvals.

Streamlining Clinical Investigations for Medical Devices Read More »