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Submitting Revised ANDA Labels to Ensure Safety & Compliance

Blogs, Regulatory /

Regulatory scrutiny for abbreviated new drug applications (ANDAs) places a strong focus on the accuracy and completeness of ANDA labels. Not only does this provide comprehensive information to healthcare professionals, but it also communicates information on medication usage and potential risks to ensure patients get clear and detailed information. This meticulous review process highlights the […]

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Development of CAR T Cell Products

Blogs, Clinical Regulatory, Regulatory /

Chimeric antigen receptor (CAR) T cell products refer to therapeutic human gene therapy products. They involve the genetic modification of T cell specificity which allows them to recognize a specific target antigen for therapeutic use.  CAR T cells are associated with many challenges related to their development, manufacturing, testing, and even clinical evaluation. Therefore, it

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Model-Integrated Evidence Program for Generic Drugs

Blogs, Regulatory /

Timely patient access to affordable treatment options is the goal of healthcare and regulatory agencies worldwide. To support this, early and frequent communication between drug applicants and regulatory agencies is required to expedite generic drug development and approval. Streamlined communication allows a better and clearer understanding of regulatory expectations and facilitates a more efficient application

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Searchable Databases for Bio-Equivalence Guidance

Blogs, Medical Writing, Regulatory /

Product-specific bioequivalence guidelines are crucial to support the development of safe, efficacious, and high-quality generic products. They provide information to manufacturers on how they can demonstrate therapeutic equivalence of their products compared to the reference drugs. Adherence to these guidelines streamline the regulatory approval process while also ensuring confidence with respect to the interchangeability of

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

Clinical Regulatory, 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

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Customized aRMM for National PV Center in Saudi Arabia

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

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Increasing Harmonization for Complex Generics

Blogs, Regulatory /

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

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Strengthening Safety Compliance in Somalia

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

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Ensuring Viral Safety of Biotechnology Products

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

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Regulatory Roadmap for Access to MedTech

Blogs, Medical Device, Regulatory /

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

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