DDReg Pharma

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DDReg Pharma

Author name: development

DDReg Features in BioPharma Dive: At the Forefront of Biotech and Pharma

Join DDReg at the Biotech Beach of the world! Meet the team at the BIO International Convention and DIA Global Annual Meeting to discuss clinical, regulatory, and safety requirements.  San Diego, often known as the “Biotech Beach,” has been a thriving center for biotech for several reasons. Its coastal location and the presence of numerous …

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Conducting Clinical Trials for Investigational Products in Brazil

Brazil is emerging as an attractive location for clinical research as it offers access to a range of patient demographics and medical facilities due to its diverse population and robust healthcare infrastructure. Conducting clinical trials for investigational products is a meticulous and highly regulated process, requiring sponsors to adhere to stringent guidelines. This ensures the …

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Controlled Correspondence for Generic Drug Development

Regulatory agencies across the globe are committed to ensuring that patients and the public have timely access to safe, effective, and high-quality medicines. They make significant developments, be it revision of guidelines to provide industry with robust support & guidance or expediting review and response times. Recently, the US FDA issued a guidance document for …

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CMC Considerations for Human Gene Therapy INDs

Human gene therapy represents a groundbreaking frontier in medicinal products for treating complex diseases. This therapy aims to transform gene expressions or modify cellular properties for therapeutic purposes. Regulatory agencies support this innovation by ensuring the required guidelines are in place. For example, the US FDA stands as a guiding beacon for sponsors that wish …

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Commitment to Biological Product and Patient Safety in India

Biological products are derived from living organisms or cells encompass a wide array of essential medical interventions, including vaccines, gene therapy products, and blood derivatives.  Thus, these products are relatively complex in nature which is why there is a need to maintain heightened vigilance and continuously monitor their safety and efficacy. It is crucial to …

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Empowering Rare Disease Drug Developers

Advanced rare disease drug developers are companies or organizations that specialize in the research and development of treatments for rare diseases. Developing drugs for rare diseases poses unique challenges due to small patient populations, genetic variations, and the need for novel endpoint selection. In response, the FDA has allocated resources through initiatives like Prescription Drug …

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DDReg Opens Entity in Singapore

The Association of Southeast Asian Nations (ASEAN) region presents an attractive opportunity for global pharmaceutical organizations that are looking to obtain market access in the respective ASEAN markets. This is due to its rapidly expanding healthcare market and harmonized regulatory processes. DDReg is thrilled to announce a significant stride in its commitment to supporting its …

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How is Team AB Gearing up for the new MedTech Legislation?

In the development of the UK’s medical device industry, a consortium of Approved Bodies (AB) united under the banner of the UK Association for Medical Device Approved Bodies, or simply, Team-AB. This coalition marks a landmark as these bodies converge to advocate for cohesive regulations in the evolving landscape of medical device oversight. The genesis …

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Harmonization for the Development of Cell and Gene Therapies

In the emerging boom of biopharmaceuticals, the remarkable advancements in cell and gene therapy (CGT) have ushered in a new era of medical possibilities. These groundbreaking treatments have the potential to revolutionize medicine, offering hope to patients with previously untreatable conditions. However, with innovation comes the need for strong regulatory frameworks to ensure safety, efficacy, …

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Essential Aspects of Labeling for Clinical Supplies and Investigational Products

With the expansion of clinical research and development, precise labeling of investigational products is not merely a formality but a critical aspect ensuring the safety, efficacy, and regulatory compliance of clinical trials. Pharmaceutical companies are obliged to follow an integrated approach in labeling considering all aspects of clinical study planning to promote multilingual and multicultural …

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