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Pharmacovigilance and Drug Safety Services in Canada | DDReg Pharma ddregpharma.com
Looking for pharmacovigilance and drug safety services in Canada? DDReg provides comprehensive adverse event reporting, signal detection, risk management, and safety analysis. Explore reliable and comprehensive solutions to monitor and ensure the safety of medications.
Pharmacovigilance in Clinical Trials: Strategies for Effective Monitoring medium.com
Discover effective strategies for monitoring pharmacovigilance in clinical trials to ensure safety and mitigate risks. Learn about essential practices and tools. DDReg to assist companies in navigating the regulatory landscape effectively and ensuring compliance throughout the drug development and post-marketing phases.
Navigating Biosimilar Regulations: Insights for Regulatory Affairs Professionals medium.com
Navigating biosimilar regulations is crucial for regulatory affairs professionals. Gain insights into the complex landscape to ensure compliance and successful market access.
AI in Healthcare and Pharmacovigilance: Revolutionizing Patient Safety medium.com
Discover how AI in healthcare and pharmacovigilance is revolutionizing patient safety. Explore the transformative power of artificial intelligence in monitoring adverse drug reactions, analyzing big data, and enhancing drug safety surveillance for better patient outcomes.
Pharmaceutical Regulatory Services in Mexico| DDReg Pharma ddregpharma.com
COFEPRIS, which stands for Comisión Federal para la Protección contra Riesgos Sanitarios (Federal Commission for Protection against Sanitary Risks), is the regulatory authority responsible for governing and overseeing Regulatory Services in Mexico. It holds the authority and expertise to control and regulate drug products within the country.
Regulatory Requirements for In-Vitro Diagnostic Devices ddregpharma.wixsite.com
Regulatory requirements for in-vitro diagnostic devices ensure their safety and efficacy, including compliance with standards, clinical evidence, and labeling guidelines.
The Importance of Preclinical Studies in Regulatory Submissions ddregpharma.blogspot.com
Preclinical studies are crucial in regulatory submissions as they provide essential data on the safety, efficacy, and potential risks of new drugs or medical devices. These studies help assess the product's effects on animals or in vitro systems, guiding decision-making and protecting human subjects during clinical trials.
The Impact of Brexit on Regulatory Affairs for Pharmaceuticals ddregpharma.mystrikingly.com
Brexit has had a significant impact on regulatory affairs for pharmaceuticals, particularly with regards to the UK's relationship with the European Medicines Agency (EMA). The UK has established its own regulatory framework, requiring separate submissions and approvals for drugs to be marketed in the UK and the EU. This has created additional costs and delays for pharmaceutical companies and has resulted in a more complex…
Understanding the Role of Regulatory Affairs in Product Development ddregpharma.wixsite.com
Regulatory Affairs ensures that products meet legal and regulatory requirements. They are crucial in product development from concept to market.
Remote Inspections – The New Normal resource.ddregpharma.com
Remote inspections have become the new normal in many industries due to the COVID-19 pandemic. Using digital tools and video conferencing, companies can conduct inspections while maintaining social distancing measures.
What Is The Scope of Pharmaceutical Regulatory Affairs in The USA? ddregpharma.wixsite.com
Pharmaceutical Regulatory Affairs in the USA involves ensuring compliance with government regulations for the development, manufacturing, and marketing of drugs. This includes submitting applications for drug approval, conducting clinical trials, and ensuring labeling and advertising adhere to regulations.
Maintaining compliance with Identification of Medicinal Products (IDMP) standards resource.ddregpharma.com
IDMP standards aim to improve patient safety by standardizing the identification, documentation, and exchange of medicinal product information. Maintaining compliance requires consistent and accurate data collection, management, and submission to regulatory agencies.
The transition from NeeS to eCTD ddregpharma.blogspot.com
The transition from NeeS to eCTD involves converting non-standardized electronic regulatory document submissions to a globally accepted standard. This requires restructuring and formatting the documents according to eCTD specifications, resulting in improved efficiency, accuracy, and consistency of the submission process.
Biosimilars uptake – An upward trend resource.ddregpharma.com
Discover how the US FDA is addressing patient concerns and removing barriers to biosimilar uptake in the pharma industry to improve access to affordable and safe treatments for complex conditions such as diabetes.
What is regulatory intelligence and why is it important? ddregpharma.wixsite.com
Regulatory intelligence (RI) in the pharmaceutical industry refers to monitoring and analyzing regulatory policies, guidelines, and laws related to the development, manufacturing, and marketing of pharmaceutical products. This helps companies minimize risk, optimize their regulatory strategy, avoid delays and fines, gain a competitive advantage, and address other regulatory issues.
The Role of Artificial Intelligence in Medical Writing and its Effects on Regulatory Compliance ddregpharma.weebly.com
Medical writing is a crucial aspect of the healthcare industry, as it involves the creation of technical documents that help in regulatory compliance and support the approval of medical products. With the advent of AI, the medical writing process has become more efficient, and the quality of documents produced has improved significantly. In this article, we will explore the role of AI in medical writing…
An overview of pharmacovigilance in Japan, USA, and Europe resource.ddregpharma.com
Pharmacovigilance is crucial to drug safety and regulatory compliance in the pharmaceutical industry. This blog post provides a comprehensive overview of pharmacovigilance in Japan, the USA, and Europe. The post covers the regulatory frameworks of these regions and how they differ, as well as the key principles and guidelines that govern pharmacovigilance practices.
Combination products: a regulatory perspective resource.ddregpharma.com
Combination products are an integral part of healthcare as they provide innovative treatment options for complex diseases. They can be as simple as a first aid kit with vials & syringes or as complex as antibody-drug conjugates combined with drugs [1].
Role of Regulatory Affairs in the Pharmaceutical Industry resource.ddregpharma.com
Regulatory Affairs experts play a crucial role in developing, approving, and monitoring drugs and medical devices. They are involved in all process phases, even after approval and commercialization. With their unique blend of scientific and management skills, they are well-equipped to achieve the commercially important goals of a drug development organization. Read “Role of Regulatory Affairs in the Pharmaceutical Industry” to learn more.
How to adapt to the eCTD 4.0 successfully? ddregpharma.blogspot.com
In order to strategically and effectively adopt the eCTD 4.0 standard, organizations must give time and develop a strategic & comprehensive approach that starts from identifying gaps to constant evaluation of the eCTD 4.0 submissions. Partnering with experts in the field can help support the transition to the new standard which provides regulatory solutions to some of the challenges faced by organizations that rely on paper-based submissions.
Drug registration process in South Korea ddregpharma.wixsite.com
The drug registration process in South Korea can be complex and time-consuming, but it is essential for pharmaceutical companies looking to bring their products to market. At DDReg Pharma, our expert team has extensive knowledge and experience in regulatory compliance and approval and can provide comprehensive solutions to help you streamline the process.
Regulatory Information Management Systems (RIMS) resource.ddregpharma.com
Managing regulatory information for a pharmaceutical product along all stages of its life cycle is a key challenge in the pharmaceutical industry.
Mitigating medical device shortages in public health emergencies resource.ddregpharma.com
The onset of the pandemic amplified an already growing concern in the European Union (EU)- the shortage of medicines, equipment, and devices that subsequently burdens the health system and puts patients at risk.
Why is a regulatory strategy important for medical devices? ddregpharma.blogspot.com
A regulatory strategy for a product aligns the regulatory activities involved with a business goal or strategy to help deliver market access to the product. It also helps highlight problem areas and challenges, and proposed regulatory solutions to tackle these challenges.
What is GxP, and what are its regulatory requirements? ddregpharma.wixsite.com
GxP refers to guidelines and regulations that ensure the quality and safety of pharmaceutical products, medical devices, and food products. GxP is an umbrella term that includes Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and other related regulations. These regulations are enforced by various regulatory agencies worldwide, including the US Food and Drug Administration (FDA) and the European Medicines Agency…
Regulatory Strategy for Medical Devices Approval ddregpharma.mystrikingly.com
If you're developing a medical device, navigating the complex approval process can be daunting. That's why we've created a comprehensive guide to regulatory strategy for medical device approval. Our guide covers the latest regulations and compliance requirements to help you avoid costly mistakes and ensure a successful approval. Visit us to learn more about the Regulatory Strategy for Medical Devices Approval.
Access to Orphan Drugs in Hereditary Angioedema resource.ddregpharma.com
Hereditary angioedema (HAE) is considered a rare, autosomal dominant disease that is characterized by repeated episodes of swelling which can occur on the face, limbs and even the gastrointestinal and respiratory tracts leading to severe pain, vomiting, and asphyxiation.
Challenges in Medic-regulatory writing ddregpharma.blogspot.com
Medical writing in regulatory affairs, also referred to as medico-regulatory writing, is one of the most crucial components for obtaining pharmaceutical market approval. Regulatory authorities around the world largely depend on the documents that have been devised by medical writers as they contain necessary scientific and safety information on the product.
The role of pharmaceutical regulatory agencies in ensuring the safety of drug products resource.ddregpharma.com
This blog post discusses the role of digitalization in regulatory affairs, its impact on the pharmaceutical industry, and some examples of what's being done now.
EMA Outlines Strategic Goals for Ensuring Patient Safety in EU Medicines Regulation resource.ddregpharma.com
Developing and approving new medicines can be a complex and time-consuming process, and ensuring patient safety and promoting transparency and innovation are essential components. In a recent article, the EMA has outlined its approach to addressing these challenges and its future goals. By taking a closer look at this article, you can gain insight into the EMA's regulatory framework and specific areas of interest, helping…