DDReg pharma

DELIVER BETTER DATA TO ENSURE FASTER APPROVAL
DDReg Pharma

RESOURCE

CENTER

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FDA’s First Draft Guidance on Nonclinical Development of Oligonucleotides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FDA’s First Draft Guidance on Nonclinical Development of Oligonucleotides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…

Importance of Collaboration between Global Regulators
18Mar

Importance of Collaboration between Global Regulators

Regulatory authorities across the globe play a pivotal role in…

DDReg Opens German Entity in Cologne (Köln)
14Mar

DDReg Opens German Entity in Cologne (Köln)

DDReg is thrilled to announce a significant milestone that is…

Submitting Revised ANDA Labels to Ensure Safety & Compliance
13Mar

Submitting Revised ANDA Labels to Ensure Safety & Compliance

Regulatory scrutiny for abbreviated new drug applications (ANDAs) places a…

Development of CAR T Cell Products
04Mar

Development of CAR T Cell Products

Chimeric antigen receptor (CAR) T cell products refer to therapeutic…

Model-Integrated Evidence Program for Generic Drugs
27Feb

Model-Integrated Evidence Program for Generic Drugs

Timely patient access to affordable treatment options is the goal…

Searchable Databases for Bio-Equivalence Guidance
22Feb

Searchable Databases for Bio-Equivalence Guidance

Product-specific bioequivalence guidelines are crucial to support the development of…

The Advancements of Gene Editing Technology for Safe and Effective Gene Therapy Products
19Feb

The Advancements of Gene Editing Technology for Safe and Effective Gene Therapy Products

The field of gene therapy has witnessed significant advancements with…

Increasing Harmonization for Complex Generics
14Feb

Increasing Harmonization for Complex Generics

Regulatory agencies across the globe are increasing their efforts in…

Strengthening Safety Compliance in Somalia
12Feb

Strengthening Safety Compliance in Somalia

The National Medicine Regulatory Authority (NMRA) of the Ministry of…

Ensuring Viral Safety of Biotechnology Products
08Feb

Ensuring Viral Safety of Biotechnology Products

Biotechnology products that are derived from cell lines are associated…

Regulatory Roadmap for Access to MedTech
05Feb

Regulatory Roadmap for Access to MedTech

In an era driven by technological advancements, particularly in healthcare,…

Fostering Medical Innovation with Expedited Review Processes
02Feb

Fostering Medical Innovation with Expedited Review Processes

2023 marked a significant year in the pharmaceutical industry as…

Easing Requirements for Minimal Risk Clinical Trials
29Jan

Easing Requirements for Minimal Risk Clinical Trials

Expediting clinical trials that post minimal risk is important to…

Standardizing Real World Data for Drug and Biological Product Submissions
25Jan

Standardizing Real World Data for Drug and Biological Product Submissions

Real world data (RWD) is proving to be an important…

Streamlining Clinical Investigations for Medical Devices
23Jan

Streamlining Clinical Investigations for Medical Devices

Clinical investigations for medicinal devices are critical in order to…

DDReg Managing Director wins ET RE Pharma “Woman Icon of the Year” Award 2024
22Jan

DDReg Managing Director wins ET RE Pharma “Woman Icon of the Year” Award 2024

The 4th edition of the Economic Times (ET) RE Pharma…

Third Party Review Program for Medical Devices
18Jan

Third Party Review Program for Medical Devices

The onset of the pandemic highlighted many obstacles pertaining to…

SwissMedic: Strengthening Safety Signal Reporting for Veterinary Products
15Jan

SwissMedic: Strengthening Safety Signal Reporting for Veterinary Products

Efficiently detecting safety signals for veterinary products is crucial for…

Effective Communication for the Safe Use of Biosimilars
11Jan

Effective Communication for the Safe Use of Biosimilars

Biosimilars and interchangeability with biologics has been a topic of…

Indian Pharmacopoeia Commission: Safety Alert for Mefenamic Acid
08Jan

Indian Pharmacopoeia Commission: Safety Alert for Mefenamic Acid

Pharmacovigilance in India has come a long way over the…

The Use of Item Response Theory in Clinical Outcome Assessments
05Jan

The Use of Item Response Theory in Clinical Outcome Assessments

Clinical outcome assessments (COAs) are a critical component of clinical…

Enhancing Medical Device Cybersecurity
03Jan

Enhancing Medical Device Cybersecurity

The integration of wireless, Internet, and network-connected capabilities in medical…

Utilizing Real-World Evidence for Medical Devices
02Jan

Utilizing Real-World Evidence for Medical Devices

Recent years have witnessed a surge in clinical practice data…

Quality Assurance and Compliance
27Dec

Quality Assurance and Compliance

Ensuring that products and services meet the highest standards of…

Reforming ANDA Suitability Petitions
21Dec

Reforming ANDA Suitability Petitions

Pharmaceutical companies have faced delays in receiving a response to…

Online Eligibility Checker Tool for International Recognition Procedure
19Dec

Online Eligibility Checker Tool for International Recognition Procedure

The International Recognition Procedure (IRP), initiated by the Medicines and…

DDReg participates in the DIA-US FDA-ANDA workshop
15Dec

DDReg participates in the DIA-US FDA-ANDA workshop

Regulatory policies that govern generic drug applications, like the Abbreviated…

UK MHRA: Navigating Nuances in Clinical Trial Applications
15Dec

UK MHRA: Navigating Nuances in Clinical Trial Applications

The UK Medicines and Healthcare products Regulatory Agency (MHRA) receives…

Fostering bilateral trade and harmonized efforts in medicine regulation
12Dec

Fostering bilateral trade and harmonized efforts in medicine regulation

The importance of aligning pharmaceutical regulations in the development process…