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Pharmacovigilance services in Australia | DDReg Pharma ddregpharma.com
DDReg Pharma
1 day ago in Health
The TGA requires medicine sponsors to have a robust PV system in place including a Qualified Person Responsible for Pharmacovigilance in Australia (QPPVA). As part of our Pharmacovigilance services in Australia, we help our customers establish a QPPVA.
Navigating Post-Marketing Regulatory Requirements: Ensuring Drug Safety and Surveillance ddregpharma.wixsite.com
DDReg Pharma
5 days ago in Health
Learn how to navigate post-marketing regulatory requirements for drug safety and surveillance to ensure patient well-being and regulatory compliance.
The Importance of Regulatory Certification for Pharmaceutical Products ddregpharma.wixsite.com
DDReg Pharma
2 weeks ago in Outsourcing
If you are a pharmaceutical company, regulatory certification is essential in ensuring your products' safety, quality, and trust. It is required for pharmaceutical products to be marketed in most countries. It involves a rigorous evaluation of a product's manufacturing, testing, and labeling practices to ensure they meet all applicable standards. Read our latest blog to learn more.
Ensuring Data Integrity in Regulatory Submissions: Challenges and Solutions ddregpharma.mystrikingly.com
DDReg Pharma
2 weeks ago in Health
Ensuring data integrity in regulatory submissions is crucial for compliance. Discover the challenges faced and effective solutions for maintaining data integrity in this critical process.
The Challenges of Digital Health Technology in India- DDReg Pharma resource.ddregpharma.com
DDReg Pharma
3 weeks ago in Outsourcing
Digital health technology is rapidly transforming the healthcare landscape in India. Driven by the COVID-19 pandemic, the adoption of digital health has accelerated, with telemedicine, health monitoring apps, and other technologies becoming increasingly commonplace. However, there are some challenges that need to be addressed to fully realize the potential of digital health in India. Please read our blog to learn more.
Expert Pharmacovigilance services in UAE by DDReg ddregpharma.com
DDReg Pharma
3 weeks ago in Outsourcing
Pharmacovigilance is an important part of ensuring the safety of medicines for patients. Companies that provide pharmacovigilance services in the UAE are vital in protecting public health. DDReg Pharma offers pharmacovigilance services in the UAE, including ADR reporting and management, signal detection, and analysis. Please reach out to our consultants to know more.
Regulatory Requirements for In-Vitro Diagnostic Devices ddregpharma.wixsite.com
DDReg Pharma
3 weeks ago in Health
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
DDReg Pharma
4 weeks ago in Health
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
DDReg Pharma
1 month ago in Health
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
DDReg Pharma
1 month ago in Health
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
DDReg Pharma
2 months ago in Health
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
DDReg Pharma
2 months ago in Health
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
DDReg Pharma
2 months ago in Health
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
DDReg Pharma
2 months ago in Health
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
DDReg Pharma
2 months ago in Health
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
DDReg Pharma
2 months ago in Health
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
DDReg Pharma
3 months ago in Technology and Gadgets
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
DDReg Pharma
3 months ago in Health
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
DDReg Pharma
3 months ago in Health
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
DDReg Pharma
3 months ago in Health
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
DDReg Pharma
3 months ago in Health
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
DDReg Pharma
3 months ago in Health
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
DDReg Pharma
3 months ago in Health
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
DDReg Pharma
3 months ago in Health
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
DDReg Pharma
3 months ago in Health
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
DDReg Pharma
3 months ago in Business and Career
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
DDReg Pharma
3 months ago in Health
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
DDReg Pharma
3 months ago in Health
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
DDReg Pharma
3 months ago in Health
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
DDReg Pharma
4 months ago in Health
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.