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Cybersecurity in Connected Medical Devices in Modern Health

Cybersecurity in Connected Medical Devices: Compliance and Risk Mitigation

All Category, Blogs, Medical Device, regulatory /

The integration of connected medical devices into healthcare systems has revolutionized patient care, enabling real-time monitoring and data-driven decision-making. However, this interconnectedness also introduces significant cybersecurity risks that can compromise patient safety, data privacy, and the integrity of healthcare operations. As cyber threats evolve, it is imperative for manufacturers, healthcare providers, and regulators to adopt […]

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Point-of-Care Diagnostics in Healthcare

Point of Care Diagnostics Making Healthcare More Accessible 

All Category, Blogs, Clinical Regulatory, Medical Device, regulatory /

Point-of-care diagnostics (POC) represent one of the fastest-growing segments in the global in-vitro diagnostics (IVD) industry, enabling rapid medical testing at or near the site of patient care. This capability significantly reduces diagnostic turnaround times, facilitates immediate clinical decision-making, and improves patient outcomes, especially in resource-limited or time-critical scenarios. The convergence of advanced biosensor technologies,

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Digital therapeutics (DTx) for Empowering Patients

Digital Therapeutics: Empowering Patients to Take Charge of Chronic Conditions 

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Chronic conditions such as diabetes, hypertension, COPD, and depression account for over 70% of global healthcare costs and are the leading cause of disability-adjusted life years (DALYs) worldwide (WHO, 2024). Traditional care pathways, while effective, often rely on episodic clinician interactions, leaving gaps in ongoing patient engagement, self-management, and behavior modification.    Digital Therapeutics (DTx)

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How Pharmacogenomics Is Powering Personalized Medicine

Your Genes, Your Treatment Plan: How Pharmacogenomics Is Powering Personalized Medicine

All Category, Blogs, Clinical Regulatory, regulatory /

A patient walks into a clinic. Two people have the same diagnosis, yet their treatments are completely different. One responds quickly. The other experiences side effects. The difference? Their genes.    Welcome to the world of pharmacogenomics, where your genetic blueprint guides your treatment plan. This isn’t a glimpse of future medicine, it’s already reshaping

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Regulatory expertise for medical device approval in India

Achieve Faster Medical Device Approval in India with Regulatory Expertise

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India’s medical device market is one of the fastest growing in the world, According to Invest India, India’s medical device market valued at around USD 11 billion in 2022–23, is projected to reach USD 50 billion by 2030, growing at a CAGR of approximately 16.4% [Report]. As global manufacturers and startups set their sights on this high-potential market, regulatory

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mexico cosmetic product registration process according to cofepris guidelines

COFEPRIS Cosmetics Registration Process: Guide for Global Brands Entering Mexico 

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As the Mexican cosmetics market continues to expand, attracting attention from global beauty brands, understanding local regulatory requirements becomes essential for successful market entry. Navigating the complexities of Mexico’s Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), the country’s regulatory authority overseeing health and safety, is critical for ensuring that your products meet local

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generative ai transforming life sciences drug discovery and development

Exploring the Future of Generative AI in Life Sciences

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Generative Artificial Intelligence (Gen AI) has become a buzzword in the tech world, but its application goes far beyond creating content like text, images, and videos. While these creative applications are exciting, the real power of generative AI lies in its ability to generate entirely new data, models, and scientific insights transforming fields like life

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Generic drug registration and Approval process in Taiwan

Taiwan Generic Drug Registration Process

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As global pharmaceutical companies intensify their focus on Asia-Pacific markets, Taiwan has emerged as a key strategic hub offering a stable regulatory environment, robust IP protection, and a high generic drug uptake under a universal healthcare system. Despite its relatively modest population, Taiwan punches above its weight in terms of healthcare spending and quality standards. 

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SAHPRA CTM lifecycle in South Africa

Navigating SAHPRA: A Guide for Complementary and Traditional Health Products in South Africa

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Complementary and traditional health products are now subject to increasing regulatory oversight in South Africa, driven by SAHPRA’s evolving mandate. Once considered outside the formal regulatory scope, CTMs are now under increasing scrutiny by the South African Health Products Regulatory Authority (SAHPRA). This shift signals the government’s intent to ensure that all health-related products regardless

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GMP compliance for advanced therapies and biologics

GMP Compliance in the Era of Advanced Therapies and Biologics

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The global biopharmaceutical industry is undergoing a transformative shift as advanced therapy medicinal products (ATMPs) including gene therapies, somatic cell therapies, and tissue-engineered products and complex biologics become central to innovation pipelines. According to a Report by ARM, as of Q2 2025, there are over 1,900 active CGT clinical trials, 2,070 developers, and $5.0 billion in

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