development, Author at DDReg pharma

EU & USA Post-Market Surveillance (PMS) plans for medical devices

Post-Market Surveillance (PMS) in Medical Devices : USA & EU Requirements

Insights, Pharmacovigilance, Regulatory / development

As a regulatory leader, your responsibility doesn’t end with market approval, it begins there. This sentiment echoes across boardrooms and regulatory strategy meetings as post-market surveillance (PMS) becomes a critical pillar of lifecycle management in medical devices. In the times where real-world performance, patient safety, and global compliance are under the spotlight, PMS is a […]

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REMS Audits and Inspections: What You Need to Know

Blogs, Pharmacovigilance / development

Risk Evaluation and Mitigation Strategies (REMS) are special safety programs required by the U.S. Food and Drug Administration (FDA) for certain drugs and biologics with serious safety concerns. These programs are designed to ensure that a product’s benefits outweigh its risks. REMS may include strategies such as restricted distribution, prescriber certification, patient education, training, and

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Key Developments & Implications of the European Health Data Space

Blogs, Pharmacovigilance, Regulatory / development

In an age where data is often called the new oil, the healthcare sector is sitting on a goldmine of untapped potential. Every day, vast amounts of health data are generated across the European Union, offering incredible opportunities to transform the way healthcare is delivered, researched, and managed. Enter the European Health Data Space (EHDS)—a

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Environmental Risk Assessment in Pharmaceutical Development

The Role of Environmental Risk Assessment in Sustainable Pharmaceutical Development

Insights, Pharmacovigilance, Regulatory / development

When a new drug is developed, its environmental journey does not end at the pharmacy shelf. Active pharmaceutical ingredients (APIs) can enter water bodies and soils through manufacturing discharges, patient excretion, or improper disposal. If not addressed, these residues may disrupt ecosystems and pose long-term environmental risks. Environmental Risk Assessment (ERA) has thus become an

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Challenges Risk Assessment in Veterinary

Navigating the Complexities of Risk Assessment in Veterinary Pharmaceuticals

Blogs, Pharmacovigilance, Regulatory / development

The development of veterinary medicines faces numerous challenges that are unique compared to human pharmaceutical development. Although the pharmaceutical industry in both sectors is built on shared principles of safety and efficacy, the veterinary pharmaceutical industry is confronted with a significantly more complex risk environment. The distinctive risk assessment challenges of veterinary pharmaceuticals and how

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All About Software as a Medical Device (SaMD)

Understanding Software as a Medical Device (SaMD)

Blogs, Medical Device / development

The International Medical Device Regulators Forum (IMDRF) defined Software as a Medical Device (SaMD) as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device”. The FDA also aligns with this, noting SaMD runs on general-purpose computing platforms, such as smartphones or

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Overcoming Roadblocks in Global Pharmacovigilance Harmonization

Blogs, Pharmacovigilance / development

Pharmacovigilance (PV) is defined by the World Health Organization (WHO) as “the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem”. Global Pharmacovigilance Harmonization, on the other hand, refers to the process of aligning regulations, practices, and standards across countries and regions in order to

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Navigating US Regulations in Radiological Health

Blogs, Regulatory / development

Radiological health involves the safe use of radiation in medical diagnosis, treatment, and industrial applications. Its goal is to minimize unnecessary radiation exposure for patients, healthcare workers, and the public. Regulation is critical for managing the risks of ionizing radiation (such as cancer risks from excessive exposure).  As we navigate through 2025, staying informed about

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Evaluating the Role of Blockchain and IoT in Drug Development

Blogs, Regulatory / development

The pharmaceutical industry is undergoing a significant transformation, driven by the need for innovation and efficiency in pharmaceutical drug development. Drug development is a resource-intensive process that can take 10–15 years and cost billions of dollars to bring a medicine to market. One important aspect is the clinical trials, which face many challenges, including data

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Project Management to Overcome Leadership & Timeline Delays

Case Studies, Regulatory / development

Customer Requirement A pharmaceutical company required timely delivery of high-quality project management services without delays. The key objectives of the project were: Ensuring on-time and quality-driven execution of regulatory submissions Maintaining consistent project direction despite leadership changes Managing political and time pressures without compromising project timelines Ensuring timely submission of required documents from external stakeholders

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Author name: development