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Blogs

Artificial Intelligence

Enhancing medico-regulatory writing with artificial intelligence

Blogs, Medical Writing / By

Medico-regulatory writing is an important part of regulatory affairs in the Pharmaceutical and Life Sciences industry. Regulatory standards are becoming more stringent in terms of data requirements as a result of ever-changing regulations. So, it is crucial to incorporate the most updated and precise medical information into regulatory applications for pharmaceutical product approval, and to …

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Pharmacovigilance and Drug Safety

Automation in Pharmacovigilance and Drug Safety

Blogs, Pharmacovigilance / By

The integration of artificial intelligence (AI) and machine learning (ML) technology into the pharmaceutical and life sciences industry is demonstrating significant benefits on several fronts. Whether it is incorporation of real-world data into clinical investigations or automation of operations to streamline key processes, technology is driving the industry forward. Pharmacovigilance is part of the industry …

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Analytical Assessment Techniques

An overview on the analytical assessment techniques for biosimilar development

Blogs, Regulatory / By

Successful biosimilar approval is determined by how well biosimilarity can be demonstrated between the proposed product and its innovator product. An analytical biosimilarity study provides the technical data that would confirm the similarity of critical quality attributes (CQAs) of the proposed product to its innovator in terms of safety, efficacy, and potency. This constitutes comprehensive …

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Biosimilar Development

Challenges in immunogenicity assessments for biosimilar development

Blogs, Medical Writing / By

The biosimilar market is rapidly growing across the globe as patents and exclusivities for biologic products approach their expiration dates. Indeed, biosimilars offer more access due to their affordability which is a key driving factor for market development, particularly in emerging markets with growing economies. However, biosimilar development is prone to many challenges, through all …

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Biosimilars

Differences in the regulatory pathways for biosimilar development: EU vs USA

Blogs, Regulatory / By

Regulations surrounding biosimilar development are based on how well the similarity between the proposed molecule and the reference product (RP) can be demonstrated. Indeed, there is a need for increased access to cost-effective treatment for various conditions, which drives biosimilar development. Regulatory agencies such as the US Food and Drug Administration (FDA) and the European …

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Active Ingredients

US FDA draft guidance: Sameness Evaluations in an ANDA for active ingredients

Blogs, Regulatory / By

As per FDA’s pre-requisites for Abbreviated New Drug Application (ANDA) filings, applicants should be able to demonstrate their product’s sameness or similarity to its innovator product or Reference Product (RP). All the data generated by applicants on generic versions should be equivalent or the same as that for reference listed drug (RLD). The CDER recently …

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Biosimilar Products

A summary of the “Guidance on the licensing of biosimilar products”- UK MHRA

Blogs, Regulatory / By

The pharmaceutical regulatory landscape in the UK has experienced many changes since Brexit. Several guidelines have been updated for more UK-specific pharmaceutical product regulation. Among these includes the ‘Guidance on the licensing of biosimilar products’ that was first published on the 6th of May 2021 with the aim to outline clear requirements for biosimilar product …

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Key Regulatory Challenges

An overview on some key regulatory challenges in API manufacturing

Blogs, Regulatory / By

The regulatory landscape is consistently evolving as it faces ever-changing guidelines and regulations. On one hand, these patient-centric regulatory changes ensure that safe, efficacious, and high-quality pharmaceutical products reach the market. On the other hand, key stakeholders in the pharmaceutical regulatory environment face significant obstacles. Needless to say, these regulatory challenges are not limited to …

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Publishing and Submission Management

Solutions and best practices in Publishing and submission management

Blogs, Publishing / By

The electronic transfer of regulatory information and subsequent review of drug applications is now more streamlined after decades of paper-based procedures. The electronic version of the Common Technical Document (CTD), or the eCTD, is now becoming more and more common in life sciences contexts worldwide, particularly in the regulatory landscape. Therefore, organizations must get ready …

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eCTD Challenges

Challenges in eCTD Publishing & Submission Management

Blogs, Publishing / By

Electronic regulatory submissions have their roots in the late 1980s and have significantly developed over the last few years, especially in key markets. The migration from paper-based submissions to electronic submissions has revolutionized the management and exchange of regulatory information. Additionally, it enables more efficient review processes and enhances the lifecycle management of submissions. In …

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