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Patient Engagement in Healthcare: Current Trends and Future Opportunities
19Feb

Patient Engagement in Healthcare: Current Trends and Future Opportunities

For years, the focus of healthcare development and delivery has…

Collaborating for Global Success in Advanced Therapy Medicinal Products (ATMPs)
17Feb

Collaborating for Global Success in Advanced Therapy Medicinal Products (ATMPs)

Advanced Therapy Medicinal Products (ATMPs) are transforming the medical landscape,…

Navigating the Challenges of Personalized Medicine in Development
14Feb

Navigating the Challenges of Personalized Medicine in Development

The landscape of modern medicine is undergoing a revolutionary transformation,…

Leveraging Real-World Evidence to Enhance Post-Marketing Safety Globally
12Feb

Leveraging Real-World Evidence to Enhance Post-Marketing Safety Globally

Real-World Evidence (RWE) refers to clinical evidence regarding the usage…

Regulatory Challenges and Opportunities with AI in Drug Development
10Feb

Regulatory Challenges and Opportunities with AI in Drug Development

AI has emerged as a transformative force in drug development,…

How Global Collaboration Can Prevent Drug Shortages in Healthcare
07Feb

How Global Collaboration Can Prevent Drug Shortages in Healthcare

Drug shortages are an escalating global challenge, threatening the effectiveness…

How Pharmacovigilance is incorporating the concept of Patient Centricity – An Industry-Leading Approach
05Feb

How Pharmacovigilance is incorporating the concept of Patient Centricity – An Industry-Leading Approach

In healthcare, assuring the safety of medications is equally as…

Evolution of Africa’s Regulatory and Healthcare Landscape
03Feb

Evolution of Africa’s Regulatory and Healthcare Landscape

Africa’s healthcare and regulatory landscape have transformed to reflect the…

A Strategic Approach for Managing Pharma Regulatory Risks with Big Data
29Jan

A Strategic Approach for Managing Pharma Regulatory Risks with Big Data

The pharmaceutical industry’s journey into the digital age has been…

Advanced Pharmacovigilance Strategies for Rare Disease Drugs
27Jan

Advanced Pharmacovigilance Strategies for Rare Disease Drugs

Rare diseases (also referred to as orphan diseases) are diseases…

Implementing a Quality by Design (QbD) Approach in Regulatory Submissions
24Jan

Implementing a Quality by Design (QbD) Approach in Regulatory Submissions

Quality by design is a systematic approach to pharmaceutical development…

Regulatory Framework for Vaccines in United States and Europe
22Jan

Regulatory Framework for Vaccines in United States and Europe

Vaccines are among the greatest achievements of modern medicine, safeguarding…

Medical Device Regulations in the United States
21Jan

Medical Device Regulations in the United States

Medical devices are indispensable tools that help improve the ability…

Exploring Regulatory Compliance for mRNA-Based Therapeutics
20Jan

Exploring Regulatory Compliance for mRNA-Based Therapeutics

The rise of messenger RNA (mRNA) technology has transformed the…

Insight into How Real-World Data Is Transforming Pharmacovigilance
15Jan

Insight into How Real-World Data Is Transforming Pharmacovigilance

Pharmaceutical companies are in a period of great development and…

A Complete Guide to Regulatory Pathways for Biosimilars in the EU and US
13Jan

A Complete Guide to Regulatory Pathways for Biosimilars in the EU and US

In the dynamic world of pharmaceuticals, biosimilars are reshaping treatment…

Pharmaceutical Regulatory Trends and Challenges Across the Asia-Pacific Region
10Jan

Pharmaceutical Regulatory Trends and Challenges Across the Asia-Pacific Region

The Asia-Pacific (APAC) region is a rapidly growing hub for…

Risk Evaluation and Mitigation Strategies (REMS) for US Drug Development
08Jan

Risk Evaluation and Mitigation Strategies (REMS) for US Drug Development

Risk Evaluation and Mitigation Strategies (REMS) is a drug safety…

Exploring Pharmacovigilance Processes in Mexico
06Jan

Exploring Pharmacovigilance Processes in Mexico

The healthcare landscape of Latin America is evolving with pharmacovigilance…

Regulatory Landscape of Regenerative Medicines
03Jan

Regulatory Landscape of Regenerative Medicines

Regenerative medicine is a field that has emerged as a…

Tackling Global Market Access Barriers in Pharma Regulation
30Dec

Tackling Global Market Access Barriers in Pharma Regulation

A pharmaceutical product’s journey through its development lifecycle, all the…

How to Effectively Respond to FDA Form 483 and Warning Letters
27Dec

How to Effectively Respond to FDA Form 483 and Warning Letters

For companies in regulated industries like pharmaceuticals, biotechnology, and medical…

Key Differences and Market Impact of Generics and Biosimilars
23Dec

Key Differences and Market Impact of Generics and Biosimilars

“Generics” and “biosimilars” are a distinct category of drugs that…

Project Orbis: Transforming Global Cancer Treatment Access
20Dec

Project Orbis: Transforming Global Cancer Treatment Access

Cancer continues to be a major cause of mortality around…

The Impact of ISO IDMP Standards on Data Management for Medicinal Products
18Dec

The Impact of ISO IDMP Standards on Data Management for Medicinal Products

The global standardization of information exchange regarding medicinal products is…

Key Insights from FDA’s ICH M13A Bioequivalence Guidelines
17Dec

Key Insights from FDA’s ICH M13A Bioequivalence Guidelines

Bioequivalence (BE) assessment is pivotal for determining the therapeutic equivalence…

Unlocking New Potential with the AREE Update in Latin America
16Dec

Unlocking New Potential with the AREE Update in Latin America

In the rapidly evolving pharmaceutical landscape of the world, it…

Boost Efficiency and Compliance with EDRMS Solutions
13Dec

Boost Efficiency and Compliance with EDRMS Solutions

The landscape of pharmaceutical regulatory affairs is developing at a…

Harnessing AI for Enhanced Literature Monitoring in Pharmacovigilance
11Dec

Harnessing AI for Enhanced Literature Monitoring in Pharmacovigilance

In the rapidly evolving landscape of pharmaceutical safety, integrating Artificial…

A Guide to Using FDA’s eSTAR for Medical Device Submissions
09Dec

A Guide to Using FDA’s eSTAR for Medical Device Submissions

The United States Food and Drug Administration (USFDA) introduced the…

How LLMs like ChatGPT Can Simplify Regulatory Affairs for New Medical Devices
06Dec

How LLMs like ChatGPT Can Simplify Regulatory Affairs for New Medical Devices

The European Union’s Medical Device Regulation (MDR) 2017/745 has significantly…

Identifying Barriers in Reporting Medical Device Adverse Effects
04Dec

Identifying Barriers in Reporting Medical Device Adverse Effects

Medical Devices are an important part of the healthcare delivery…

Adapting to Changes in EU Pharmaceutical Laws
02Dec

Adapting to Changes in EU Pharmaceutical Laws

The European Union (EU) has long been recognized as a…

What EMA Policy 0070 Means for Global Clinical Trials and Regulatory Practices
29Nov

What EMA Policy 0070 Means for Global Clinical Trials and Regulatory Practices

In recent years, the pharmaceutical industry has been under increasing…

DDReg in the News
28Nov

DDReg in the News

The news of DDReg announcing its collaboration with Quantiphi has…

Integrating Real-World Data into Regulatory Practices of Electronic Health Records and Medical Claims
27Nov

Integrating Real-World Data into Regulatory Practices of Electronic Health Records and Medical Claims

As the healthcare and pharmaceutical industries increasingly turn to data-driven…

The Future of ATMPs under EU’s Updated SoHO Regulations
25Nov

The Future of ATMPs under EU’s Updated SoHO Regulations

The Advanced Therapy Medicinal Products (ATMPs) regulation was and covers…

Navigating the New Requirements for Diversity in Clinical Trials
21Nov

Navigating the New Requirements for Diversity in Clinical Trials

In recent years, the emphasis on diversity in clinical trials…

FDA’s First Draft Guidance on Nonclinical Development of Oligonucleotides
20Nov

FDA’s First Draft Guidance on Nonclinical Development of Oligonucleotides

The rapid evolution of biotechnology has positioned oligonucleotide-based therapeutics as…

What Biologics Developers Need to Know about ICH Q2 and Q14 Revisions
18Nov

What Biologics Developers Need to Know about ICH Q2 and Q14 Revisions

The rapid advancement of biologics and the complexity of their…

Accelerating Drug Development with Europe’s New Clinical Trial Pilots
15Nov

Accelerating Drug Development with Europe’s New Clinical Trial Pilots

The journey from discovering a promising compound to its approval…

What does the scenario of biosimilar cell and gene therapies look like?
14Nov

What does the scenario of biosimilar cell and gene therapies look like?

Cell and gene therapy (CGT) products are gradually paving the…

Complying with Safety Reporting Requirements in the EU’s CTD to CTR Transition
11Nov

Complying with Safety Reporting Requirements in the EU’s CTD to CTR Transition

Since 2004, clinical trials (CTs) in the European Union (EU)…

FDA Launches REMS Public Dashboard to Enhance Transparency and Data Access
06Nov

FDA Launches REMS Public Dashboard to Enhance Transparency and Data Access

The U.S. Food and Drug Administration has launched the REMS…

Quantiphi, DDReg Partner to Transform Regulatory Reporting in Life Sciences Through AI
06Nov

Quantiphi, DDReg Partner to Transform Regulatory Reporting in Life Sciences Through AI

Gurgaon, INDIA –  Quantiphi, a global AI-first digital engineering company…

Designing Effective Pharmaco-Epidemiological Studies with ICH’s M14
04Nov

Designing Effective Pharmaco-Epidemiological Studies with ICH’s M14

Imagine a pharmaceutical company about to launch a new drug.…

DDReg Diwali Gala 2024
01Nov

DDReg Diwali Gala 2024

Diwali is a very special time in India, where everyone…

Understanding Post-Approval Manufacturing Changes in Biosimilars and Interchangeable Products in USA
30Oct

Understanding Post-Approval Manufacturing Changes in Biosimilars and Interchangeable Products in USA

After a biosimilar or interchangeable product gets regulatory approval by…

Updates to the Declaration of Helsinki
25Oct

Updates to the Declaration of Helsinki

The Declaration of Helsinki (DoH), the first international set of…

Navigating EU Classification Standards for AI in Medical Devices and Diagnostics
22Oct

Navigating EU Classification Standards for AI in Medical Devices and Diagnostics

The European Union (EU) has introduced stringent classification standards for…

Expediting Access to Cell and Gene Therapy Products
16Oct

Expediting Access to Cell and Gene Therapy Products

In the past four decades, the number of drugs being…

Enhancing Medical Device Innovation with the Total Product Life Cycle Advisory Program
15Oct

Enhancing Medical Device Innovation with the Total Product Life Cycle Advisory Program

The medical device industry is driven by constant technological advancements…

Exploring the Evolving Regulatory Landscape for Gene Therapy Trials in the EU
08Oct

Exploring the Evolving Regulatory Landscape for Gene Therapy Trials in the EU

Gene therapy is recognized as a revolutionary approach in treating…

How EMA’s Expedited Pathways and Scientific Advice Are Shaping Drug Approvals
03Oct

How EMA’s Expedited Pathways and Scientific Advice Are Shaping Drug Approvals

At the DIA 2024 Global Annual Meeting in San Diego,…

Managing Director of DDReg chosen as finalist for CPhI Pharma Awards 2024
25Sep

Managing Director of DDReg chosen as finalist for CPhI Pharma Awards 2024

DDReg is incredibly proud to announce that our Founder and…

Japan’s Approach to eCTD V4.0
23Sep

Japan’s Approach to eCTD V4.0

In the pursuit of global harmonization in pharmaceutical regulation, Japan…

Does the FDA need a new approval pathway?
17Sep

Does the FDA need a new approval pathway?

The accelerated approval pathway is established to expedite the availability…

Regulatory Framework for Software and Artificial Intelligence as Medical Device
14Sep

Regulatory Framework for Software and Artificial Intelligence as Medical Device

The convergence of healthcare with technology has led to giant…

Navigating the 505(b)(2) Approval Pathway
03Sep

Navigating the 505(b)(2) Approval Pathway

In the early days of drug development, pioneers had two…

Specifications for In Vitro Diagnostic Devices
30Aug

Specifications for In Vitro Diagnostic Devices

In vitro diagnostic medical devices (IVD devices) are an integral…

Faster Access to Clinical Trial Information in Europe
28Aug

Faster Access to Clinical Trial Information in Europe

Improving access to clinical trial information is critical in order…

The Use of EDDO to Ensure Drug Delivery Function
23Aug

The Use of EDDO to Ensure Drug Delivery Function

When it comes to ensuring the safety and effectiveness of…

Emerging Drug Safety Technology Program
20Aug

Emerging Drug Safety Technology Program

Pharmacovigilance practices are associated with several challenges related to collection…

DDReg Celebrates 77th Independence Day
16Aug

DDReg Celebrates 77th Independence Day

At DDReg, we believe in nurturing a strong company culture…

Ensuring Transparency for Machine Learning-Enabled Medical Devices
12Aug

Ensuring Transparency for Machine Learning-Enabled Medical Devices

Transparency in Machine Learning-Enabled Medical Devices (MLMDs) refers to the…

Clinical Evaluation of Orphan Medical Devices
08Aug

Clinical Evaluation of Orphan Medical Devices

In the European Union, the Medical Device Coordination Group (MDCG)…

Safety Testing of Allogeneic Cells used in Cell Based Medical Products
02Aug

Safety Testing of Allogeneic Cells used in Cell Based Medical Products

Cell based medicinal products use a single source of cells…

Accelerating Product Registration with SFDA’s Priority Review
29Jul

Accelerating Product Registration with SFDA’s Priority Review

It is important for regulatory agencies to implement priority review…

REMS Logic Model: Framework to link program design with assessment
25Jul

REMS Logic Model: Framework to link program design with assessment

Risk Evaluation and Mitigation Strategies (REMS) helps the FDA in…

Impact of GenAI on Indian Healthcare
22Jul

Impact of GenAI on Indian Healthcare

The Indian healthcare system has been traditionally plagued by challenges…

Machine Learning and Simulations for Clinical Trials
19Jul

Machine Learning and Simulations for Clinical Trials

clinical trial simulation Artificial Intelligence (AI) entails the use of…

The Impact of Interactive Safety Graphics in Clinical Settings
11Jul

The Impact of Interactive Safety Graphics in Clinical Settings

The world of regulatory submissions is transforming where static documents…

Comprehensive Framework for Effective Clinical Trial Dialogue
08Jul

Comprehensive Framework for Effective Clinical Trial Dialogue

The need for effective clinical trial dialogue is imperative to…

Accelerating Clinical Trials in the European Union
03Jul

Accelerating Clinical Trials in the European Union

Accelerating Clinical Trials in the European Union (ACT EU) is…

DDReg Exhibits at the DIA Global Annual Meeting 2024
30Jun

DDReg Exhibits at the DIA Global Annual Meeting 2024

The Drug Information Association (DIA) Global Annual Meeting 2024 was…

DDReg Exhibits at the BIO International Convention 2024
27Jun

DDReg Exhibits at the BIO International Convention 2024

The BIO International Convention in San Diego was an exciting…

Enhancing Global Drug Development through ICH M11
25Jun

Enhancing Global Drug Development through ICH M11

The development of new drugs is a complex process involving…

Leveraging Statistical Approaches in Drug Safety Analysis
14Jun

Leveraging Statistical Approaches in Drug Safety Analysis

Drug safety in clinical trials is ensured through the application…

Center for Clinical Trial Innovation
30May

Center for Clinical Trial Innovation

Medical research is progressing rapidly to keep up with the…

Data Integrity for In Vivo BABE Studies
28May

Data Integrity for In Vivo BABE Studies

The pharmaceutical industry is evolving with technological advancements with a…

Redesigned Pre-Submission Meetings for ANDAs with the US FDA
24May

Redesigned Pre-Submission Meetings for ANDAs with the US FDA

Pre ANDA meetings facilitate pre-submission communications with the US FDA…

Electronic Submissions for Investigational New Drug Safety Reports
21May

Electronic Submissions for Investigational New Drug Safety Reports

Regulatory agencies like the United States’ FDA are increasingly encouraging…

A Collaborative Approach Towards Integrating Artificial Intelligence in Medical Products
14May

A Collaborative Approach Towards Integrating Artificial Intelligence in Medical Products

Imagine a world where medical care is not just about…

Enhancing Clinical Trial Regulations for Advanced Therapy Medicinal Products
13May

Enhancing Clinical Trial Regulations for Advanced Therapy Medicinal Products

Advanced therapy medicinal products (ATMPs) including gene therapy medicinal products,…

Pharmacovigilance in New Zealand
08May

Pharmacovigilance in New Zealand

Medsafe oversees pharmaceutical product regulation in New Zealand and operates…

Designing Early-Phase Clinical Trials for Cell and Gene Therapy Products
07May

Designing Early-Phase Clinical Trials for Cell and Gene Therapy Products

Early-phase clinical trials for cell and gene therapy (CGT) products…

Navigating Orphan Drug Regulations for Gene Therapy Products
02May

Navigating Orphan Drug Regulations for Gene Therapy Products

Human gene therapy products, like other medicines, may be eligible…

DDReg Features in BioPharma Dive: At the Forefront of Biotech and Pharma
29Apr

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

Join DDReg at the Biotech Beach of the world! Meet…

Conducting Clinical Trials for Investigational Products in Brazil
24Apr

Conducting Clinical Trials for Investigational Products in Brazil

Brazil is emerging as an attractive location for clinical research…

Controlled Correspondence for Generic Drug Development
22Apr

Controlled Correspondence for Generic Drug Development

Regulatory agencies across the globe are committed to ensuring that…

CMC Considerations for Human Gene Therapy INDs
18Apr

CMC Considerations for Human Gene Therapy INDs

Human gene therapy represents a groundbreaking frontier in medicinal products…

Commitment to Biological Product and Patient Safety in India
17Apr

Commitment to Biological Product and Patient Safety in India

Biological products are derived from living organisms or cells encompass…

Empowering Rare Disease Drug Developers
15Apr

Empowering Rare Disease Drug Developers

Advanced rare disease drug developers are companies or organizations that…

DDReg Opens Entity in Singapore
09Apr

DDReg Opens Entity in Singapore

The Association of Southeast Asian Nations (ASEAN) region presents an…

How is Team AB Gearing up for the new MedTech Legislation?
08Apr

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

In the development of the UK’s medical device industry, a…

Harmonization for the Development of Cell and Gene Therapies
01Apr

Harmonization for the Development of Cell and Gene Therapies

In the emerging boom of biopharmaceuticals, the remarkable advancements in…

Essential Aspects of Labeling for Clinical Supplies and Investigational Products
28Mar

Essential Aspects of Labeling for Clinical Supplies and Investigational Products

With the expansion of clinical research and development, precise labeling…

Assessing COVID-19 Symptoms in Clinical Trials
26Mar

Assessing COVID-19 Symptoms in Clinical Trials

The onset of the coronavirus, or COVID-19, created havoc across…

Asserting Patient Rights: The Importance of Labels for Medical Device Traceability
20Mar

Asserting Patient Rights: The Importance of Labels for Medical Device Traceability

In the realm of healthcare, patients have a fundamental right…