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Enhancing Good Clinical Practice for the Evolving Clinical Trial Landscape
08Jun

Enhancing Good Clinical Practice for the Evolving Clinical Trial Landscape

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals…

How do Artwork Management Systems help maintain FDA compliance?
06Jun

How do Artwork Management Systems help maintain FDA compliance?

The pharmaceutical industry is a highly regulated environment where investing…

Understanding the FDA’s Abbreviated New Animal Drug Application Pathway
31May

Understanding the FDA’s Abbreviated New Animal Drug Application Pathway

The level of scrutiny surrounding animal medicinal products has strengthened…

Drug-Device Products: Navigating through the EU
23May

Drug-Device Products: Navigating through the EU

Drug-device combination (DDC) products are increasingly demonstrating the value they…

DDReg features in BioPharma Dive
22May

DDReg features in BioPharma Dive

End to end global regulatory services driven through technology-enabled solutions.DDReg…

Indian Perspective on Digital Health Technology
18May

Indian Perspective on Digital Health Technology

Digital health technology has gained significant momentum in India, revolutionizing…

Challenges With Medical Devices and Digital Health Technologies
12May

Challenges With Medical Devices and Digital Health Technologies

Currently, there are over 2 million diverse types of medical…

Risk-Based Approach to Monitoring Clinical Trials
10May

Risk-Based Approach to Monitoring Clinical Trials

Introduction Clinical trial sponsors for pharmaceutical products (drugs and/or biologics…

Digital Future of Healthcare
05May

Digital Future of Healthcare

Introduction The COVID-19 pandemic and changes in legal frameworks have…

Regulatory Guidelines for Software and Artificial Intelligence as a Medical Device
03May

Regulatory Guidelines for Software and Artificial Intelligence as a Medical Device

Technological disruptors are gradually revolutionizing various aspects of life sciences…

WHO Pre-qualification pathway: advancing access to vaccines
28Apr

WHO Pre-qualification pathway: advancing access to vaccines

Introduction Malaria is one of the biggest and most pressing…

DARWIN EU – Generating Real-World Evidence to Support Regulatory Decisions
26Apr

DARWIN EU – Generating Real-World Evidence to Support Regulatory Decisions

The European Medicines Agency (EMA) has created a sustainable network…

Real-Time Remote Inspections – The New Normal
21Apr

Real-Time Remote Inspections – The New Normal

IntroductionThe onset of the pandemic was one of the most…

Rise of Digital Applications in the Healthcare Sector
17Apr

Rise of Digital Applications in the Healthcare Sector

The healthcare sector has been significantly impacted by technology, with…

Benefits of randomized control trials in accelerated approvals for oncology therapeutics
11Apr

Benefits of randomized control trials in accelerated approvals for oncology therapeutics

In 1992 the US FDA established the accelerated approval pathway…

Maintaining compliance with Identification of Medicinal Products (IDMP) standards
06Apr

Maintaining compliance with Identification of Medicinal Products (IDMP) standards

The pharmaceutical industry including its operations and associated functions run…

Biosimilars uptake – An upward trend
04Apr

Biosimilars uptake – An upward trend

The development of biologic products has increased over the last…

DDReg Exhibits at DIA Europe 2023 in Basel, Switzerland
25Mar

DDReg Exhibits at DIA Europe 2023 in Basel, Switzerland

The European Union has seen some major changes and advances…

Combination products: a regulatory perspective
15Mar

Combination products: a regulatory perspective

Combination products are an integral part of healthcare as they…

Pre-market pathways for combination products
10Mar

Pre-market pathways for combination products

The regulatory landscape for combination products has been somewhat of…

Mitigating medical device shortages in public health emergencies
03Mar

Mitigating medical device shortages in public health emergencies

The onset of the pandemic amplified an already growing concern…

Access to Orphan Drugs in Hereditary Angioedema
28Feb

Access to Orphan Drugs in Hereditary Angioedema

IntroductionHereditary angioedema (HAE) is considered a rare, autosomal dominant disease…

Digitalization in Regulatory Affairs
23Feb

Digitalization in Regulatory Affairs

Technology is rapidly driving the growth of the Pharmaceutical and…

Medical Devices – Considerations for preparing a Clinical Evaluation Report (CER)
21Feb

Medical Devices – Considerations for preparing a Clinical Evaluation Report (CER)

Overview Medical Device manufacturers must demonstrate the safety, efficacy, and…

EU regulatory strategic goals for human medicines
15Feb

EU regulatory strategic goals for human medicines

The European regulatory system constitutes a network of pharmaceutical regulators…

We are exhibiting at DIA Europe 2023
13Feb

We are exhibiting at DIA Europe 2023

We are exhibiting at DIA Europe 2023 Meet our experts…

Additional Risk Minimization Measures: Pregnancy Prevention Programme
10Feb

Additional Risk Minimization Measures: Pregnancy Prevention Programme

IntroductionThe practice of pharmacovigilance revolves around patient safety by improving…

Pharmacovigilance for Biosimilars vs pharmacovigilance for generics
08Feb

Pharmacovigilance for Biosimilars vs pharmacovigilance for generics

The Eprex®-pure red cell aplasia case of 1998 engendered the…

An overview on pharmacovigilance in Japan, USA, Europe
03Feb

An overview on pharmacovigilance in Japan, USA, Europe

The International Conference on Harmonization of Technical Requirements for the…

What do you need to know about aggregate reporting?
01Feb

What do you need to know about aggregate reporting?

Overview Pharmacovigilance (PV) and post-market surveillance is important to capture…

Components of a risk management plan in pharmacovigilance
25Jan

Components of a risk management plan in pharmacovigilance

Overview A drug is authorized by an agency only when…

Social & Digital Media Sources in Drug Safety
20Jan

Social & Digital Media Sources in Drug Safety

A crucial part of pharmacovigilance (PV) and post-market drug safety…

Challenges in ICSR processing
17Jan

Challenges in ICSR processing

Individual Case Safety Reports (ICSRs) are a key aspect of…

Signal Management
12Jan

Signal Management

A signal is information that arises from single or multiple…

Structured Product Labeling
12Jan

Structured Product Labeling

Structured Product Labeling (SPL) was first introduced in 2006 by…

Preparedness for inspections: Are you prepared for the upcoming pharmacovigilance inspection?
03Jan

Preparedness for inspections: Are you prepared for the upcoming pharmacovigilance inspection?

Regulatory authorities around the world conduct pharmacovigilance (PV) inspections to…

Enhancing medico-regulatory writing with artificial intelligence
14Dec

Enhancing medico-regulatory writing with artificial intelligence

Medico-regulatory writing is an important part of regulatory affairs in…

Automation in Pharmacovigilance and Drug Safety
12Dec

Automation in Pharmacovigilance and Drug Safety

The integration of artificial intelligence (AI) and machine learning (ML)…

Convergence of regulatory frameworks surrounding cell, tissue, and gene therapy products
08Dec

Convergence of regulatory frameworks surrounding cell, tissue, and gene therapy products

Cell, tissue, or gene therapy products (CTGTPs) can contain non-viable…

An overview on the analytical assessment techniques for biosimilar development
06Dec

An overview on the analytical assessment techniques for biosimilar development

Successful biosimilar approval is determined by how well biosimilarity can…

Challenges in immunogenicity assessments for biosimilar development
01Dec

Challenges in immunogenicity assessments for biosimilar development

The biosimilar market is rapidly growing across the globe as…

Differences in the regulatory pathways for biosimilar development: EU vs USA
25Nov

Differences in the regulatory pathways for biosimilar development: EU vs USA

Regulations surrounding biosimilar development are based on how well the…

US FDA draft guidance: Sameness Evaluations in an ANDA for active ingredients
22Nov

US FDA draft guidance: Sameness Evaluations in an ANDA for active ingredients

As per FDA’s pre-requisites for Abbreviated New Drug Application (ANDA)…

A summary of the “Guidance on the licensing of biosimilar products”- UK MHRA
17Nov

A summary of the “Guidance on the licensing of biosimilar products”- UK MHRA

The pharmaceutical regulatory landscape in the UK has experienced many…

An overview on some key regulatory challenges in API manufacturing
15Nov

An overview on some key regulatory challenges in API manufacturing

The regulatory landscape is consistently evolving as it faces ever-changing…

Solutions and best practices in Publishing and submission management
18Oct

Solutions and best practices in Publishing and submission management

The electronic transfer of regulatory information and subsequent review of…

Challenges in eCTD Publishing & Submission Management
17Oct

Challenges in eCTD Publishing & Submission Management

Electronic regulatory submissions have their roots in the late 1980s…

Adalimumab as a treatment choice for Rheumatoid Arthritis- a pharmacoeconomic perspective
12Oct

Adalimumab as a treatment choice for Rheumatoid Arthritis- a pharmacoeconomic perspective

Arthritis is an inflammatory condition that affects people worldwide leading…

European Medicines Agency: Biosimilar medicines can be interchanged
03Oct

European Medicines Agency: Biosimilar medicines can be interchanged

A biosimilar medicine is one that demonstrates high similarity to…

Overview on Cardiovascular Medical Device Regulation by the FDA
29Sep

Overview on Cardiovascular Medical Device Regulation by the FDA

According to the World Health Organization (WHO), cardiovascular diseases (CVD)…

Increasing access to contraceptive implants for better and safe family planning
26Sep

Increasing access to contraceptive implants for better and safe family planning

Access to contraceptive options for reproductive health helps women in…

ICSR PROCESSING & PATIENT SAFETY
16Sep

ICSR PROCESSING & PATIENT SAFETY

Adverse event processing & causality assessment is the preferred way…

Pharmacovigilance Services at DDReg: Our commitment towards Patient Safety
15Sep

Pharmacovigilance Services at DDReg: Our commitment towards Patient Safety

An important aspect of patient safety is Pharmacovigilance, that is…

Medication errors: Self-medication
14Sep

Medication errors: Self-medication

Florence Nightingale once said “The very first requirement in a…

Understanding the EU Clinical Trial Information System
01Sep

Understanding the EU Clinical Trial Information System

The European Union (EU) implemented significant changes in the way…

Treating Clostridium difficile infections using biotherapeutics
24Aug

Treating Clostridium difficile infections using biotherapeutics

Treating Clostridium difficile infections using biotherapeutics Biotherapeutics are therapies that…

DDReg receives the ISO 27001:2013 certification for Information Security Management System
08Aug

DDReg receives the ISO 27001:2013 certification for Information Security Management System

Ever since the incorporation, it has been DDReg’s endeavor to…

Why is an ISO 27001 important for an organization?
08Aug

Why is an ISO 27001 important for an organization?

In a technology driven era where businesses are increasingly incorporating…

Regulatory Information Management Systems (RIMS)
28Jul

Regulatory Information Management Systems (RIMS)

Managing regulatory information for a pharmaceutical product along all stages…

Role of Regulatory Affairs in the Pharmaceutical Industry
20Jul

Role of Regulatory Affairs in the Pharmaceutical Industry

The pharmaceutical industry is one that is highly regulated by…

India’s New Drugs, Medical Devices and Cosmetics Bill 2022
15Jul

India’s New Drugs, Medical Devices and Cosmetics Bill 2022

Drug laws & regulations in India have roots that are…

DDReg celebrates its 13th Foundation Day
05Jul

DDReg celebrates its 13th Foundation Day

On Friday 1st July 2022, DDReg Pharma wholeheartedly celebrated its…

Quality Management Maturity Program by the CDER of the U.S. FDA
28Jun

Quality Management Maturity Program by the CDER of the U.S. FDA

The pharmaceutical industry is one that is constantly growing and…

Technological transformation in Pharmacovigilance
16Jun

Technological transformation in Pharmacovigilance

Technological disruption is rapidly occurring across all industries. In the…

Outsourcing regulatory compliance solutions
14Jun

Outsourcing regulatory compliance solutions

In an era of technological advancement, and easy access to…

Nanobodies vs antibodies in the fight against Covid
18May

Nanobodies vs antibodies in the fight against Covid

Nanobodies are engineered small proteins that recognize and specifically bind…

Enhancing drug discovery processes through artificial intelligence
05May

Enhancing drug discovery processes through artificial intelligence

From pre-clinical phases to post-marketing follow up studies, the drug…

DDReg to participate in CPhI North America conference in Philadelphia from 17th-19th May, 2022
04May

DDReg to participate in CPhI North America conference in Philadelphia from 17th-19th May, 2022

CPhI provides a networking platform for pharmaceutical industry leaders. As…

Is QPPV training essential?
29Apr

Is QPPV training essential?

Drug safety is all about the right patient receiving the…

The impact of the Russia-Ukraine war on clinical trials
19Apr

The impact of the Russia-Ukraine war on clinical trials

The Russia-Ukraine war has undoubtedly affected millions of people in…

DDReg’s RegTech space: your regulatory solution for achieving rapid market access
06Apr

DDReg’s RegTech space: your regulatory solution for achieving rapid market access

RegTech focuses on technologies that may facilitate the delivery of…

DDReg Pharma: Silver Sponsors of the 7th GCC Pharma Summit 2022, Dubai, UAE
25Mar

DDReg Pharma: Silver Sponsors of the 7th GCC Pharma Summit 2022, Dubai, UAE

The healthcare ecosystem is driven by several factors. Government vision,…

Biologics development & regulatory approval – EMA perspective
25Feb

Biologics development & regulatory approval – EMA perspective

Biologic medicinal products, particularly biosimilars, have revolutionized the treatment of…

Biosimilarity and Interchangeability in the MENA region
11Feb

Biosimilarity and Interchangeability in the MENA region

A biological drug (or biologic) is one that is produced…

DDReg enters into RegTech Space
04Feb

DDReg enters into RegTech Space

Smart regulatory processes and regulatory intelligence have evolved over past…

Biosimilars in the Emerging World
23Jan

Biosimilars in the Emerging World

Over the last five years, biosimilars have progressively gained traction.…

African Medicines Agency
01Dec

African Medicines Agency

In 2019, the African Union’s Bureau of Heads of State…

Integrative Medicine
16Nov

Integrative Medicine

Integral health integrates traditional treatment in a coordinated way with…

Knowledge Management in Regulatory Affairs (KMRA)
21Oct

Knowledge Management in Regulatory Affairs (KMRA)

Knowledge management (KM) has been a recognized discipline in other…

Telehealth – Regulatory Perspective
16Sep

Telehealth – Regulatory Perspective

The COVID-19 pandemic has forced healthcare systems to drastically and quickly…

Expanded use of RWE (Real World Evidence)
27Aug

Expanded use of RWE (Real World Evidence)

With a laser-like emphasis on results and value, healthcare is…

Artificial Intelligence – Impact on The Global Pharma Industry
13Aug

Artificial Intelligence – Impact on The Global Pharma Industry

One of the fastest expanding technologies on the planet at…

Identification of Medicinal Products (IDMP) – The Perspective of US FDA & EMA
03Aug

Identification of Medicinal Products (IDMP) – The Perspective of US FDA & EMA

IDMP is a progression of five specific guidelines established by…

Controlled Correspondence with FDA – An Update
26Mar

Controlled Correspondence with FDA – An Update

The US Food and Drug Administration (FDA) has recently finalized…

Generic Drug User Fee Amendments
28Oct

Generic Drug User Fee Amendments

The US generic drug industry has grown into a major…

Impact of Brexit on the Pharmaceutical Industry
28Oct

Impact of Brexit on the Pharmaceutical Industry

The pharmaceutical industry is one of the most important industries…

Nitrosamine Impurities: A Regulatory Perspective
28Oct

Nitrosamine Impurities: A Regulatory Perspective

In July 2018, the European medicines regulatory network became aware…