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How is EMA Addressing Medicine Shortages in Europe?
28Nov

How is EMA Addressing Medicine Shortages in Europe?

The emergence of drug shortages as a significant global health…

Kenya’s Systematic Approach to Pharmacovigilance
22Nov

Kenya’s Systematic Approach to Pharmacovigilance

Pharmacovigilance (PV) and drug safety surveillance activities rely on a…

MHRA’s AI-Airlock for Safe Development of Medical Technologies
20Nov

MHRA’s AI-Airlock for Safe Development of Medical Technologies

The use of artificial intelligence (AI) in the Pharmaceutical and…

Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices
17Nov

Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices

As more artificial intelligence (AI) and machine learning (ML) technologies…

ISoP: The Need for Patient Engagement in Pharmacovigilance
16Nov

ISoP: The Need for Patient Engagement in Pharmacovigilance

Pharmacovigilance is paramount for the well-being of patients exposed to…

DDReg’s Diwali Celebration 2023
09Nov

DDReg’s Diwali Celebration 2023

Diwali is a time filled with happiness, togetherness, and festivities-…

AMDF: Ensuring the Safety of Donated Medical Devices
07Nov

AMDF: Ensuring the Safety of Donated Medical Devices

In times of emergencies like war, disease outbreak, natural disasters…

DDReg attends the OTC Health and Wellness Conference 2023
06Nov

DDReg attends the OTC Health and Wellness Conference 2023

The OTC Health and Wellness Conference was held on the…

Japan PMDA: The Role of In-Country Clinical Caretakers
02Nov

Japan PMDA: The Role of In-Country Clinical Caretakers

Japan has a robust regulatory framework for pharmaceuticals and medical…

Regulatory Framework for Cosmetics in South Korea
31Oct

Regulatory Framework for Cosmetics in South Korea

The cosmetics sector in South Korea has witnessed impressive expansion…

Pharmacovigilance in Herbal and Alternative Medicine
27Oct

Pharmacovigilance in Herbal and Alternative Medicine

At the turn of the millennium, guidelines for post-marketing safety…

DDReg attends CPHI Barcelona
27Oct

DDReg attends CPHI Barcelona

CPHI Barcelona was held on 24th to 26th of October…

DDReg nominated for India 5000 Best MSME Awards 2023
21Oct

DDReg nominated for India 5000 Best MSME Awards 2023

DDReg is thrilled to announce its successful nomination for the…

Supporting Labelling Compliance with Searchable Databases
19Oct

Supporting Labelling Compliance with Searchable Databases

Biopharmaceutical product labelling is a multifaceted undertaking that spans various…

Swissmedic: The Importance of Real-World Evidence in Regulatory Decision Making
17Oct

Swissmedic: The Importance of Real-World Evidence in Regulatory Decision Making

Real-World Evidence (RWE) refers to clinical evidence derived from real-world…

Modernization of Cosmetics Regulation Act
11Oct

Modernization of Cosmetics Regulation Act

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents…

Ensuring Safe Use of Medical Devices in Healthcare Facilities
10Oct

Ensuring Safe Use of Medical Devices in Healthcare Facilities

The safe and effective use of medical devices in healthcare…

Evaluating the need for comparative clinical efficacy studies in biosimilar development
04Oct

Evaluating the need for comparative clinical efficacy studies in biosimilar development

Introduction Long-term safety, efficacy, and immunogenicity data of licensed biosimilars…

Prescription-Drug-Use-Related Software
03Oct

Prescription-Drug-Use-Related Software

Introduction With the advancement in digital technology, the development of…

DDReg Shortlisted for ‘Regulatory’ by CPHI Pharma Awards 2023
29Sep

DDReg Shortlisted for ‘Regulatory’ by CPHI Pharma Awards 2023

DDReg is thrilled to announce that it has made it…

Requesting Post-Warning Letter Meetings
28Sep

Requesting Post-Warning Letter Meetings

During an inspection, the US FDA may detect that the…

Navigating Drug Manufacturing Inspections
26Sep

Navigating Drug Manufacturing Inspections

The US FDA conducts drug manufacturing inspections for facilities to…

DDREG & OKTANE HR – Training and Development Program for Employees
21Sep

DDREG & OKTANE HR – Training and Development Program for Employees

DDReg took a significant stride toward nurturing its team’s potential…

UK MHRA International Recognition Procedure
20Sep

UK MHRA International Recognition Procedure

The UK MHRA’s Latest Update on the International Recognition Procedure…

How does EMA use Artificial Intelligence and Large Language Models in Medicine Regulation?
18Sep

How does EMA use Artificial Intelligence and Large Language Models in Medicine Regulation?

Artificial Intelligence in Medicine Regulation– a perspective by Emer Cooke,…

Formal Meetings for Biosimilar Product Development with the US FDA
14Sep

Formal Meetings for Biosimilar Product Development with the US FDA

Comprehending the Key Components of Formal Meetings for Biosimilar Development…

Paediatric Investigation Plan in Medicinal Product Development
12Sep

Paediatric Investigation Plan in Medicinal Product Development

Navigating the Paediatric Investigation Plan and its Significance in the…

Packaging Requirements for the Safety of Children
05Sep

Packaging Requirements for the Safety of Children

Saudi Food and Drug Authority’s Requirements on Child-Resistant Packaging for…

Post-market safety data for underrepresented populations in clinical trials
01Sep

Post-market safety data for underrepresented populations in clinical trials

Introduction Regulatory agencies require sponsors to collect and provide data…

How to prepare for oral explanations with EMA
29Aug

How to prepare for oral explanations with EMA

A marketing authorisation application (MAA) can take up to 210…

Guidance on Informed Consent in Clinical Investigations
24Aug

Guidance on Informed Consent in Clinical Investigations

Within the realm of clinical research, the process of obtaining…

Diversity Plan in Clinical Trials
22Aug

Diversity Plan in Clinical Trials

The importance of recruiting diverse patients for clinical trials in…

US FDA: Enhancing the safety of cosmetic products
17Aug

US FDA: Enhancing the safety of cosmetic products

In the ever-evolving landscape of personal care and aesthetics, cosmetic…

Overcoming challenges in determining AI limits for NDSRIs
14Aug

Overcoming challenges in determining AI limits for NDSRIs

Introduction Nitrosamine Drug Substance-Related Impurities (NDSRIs) share structural similarity with…

Mandating CADIFA for drug registration in Brazil
10Aug

Mandating CADIFA for drug registration in Brazil

Navigating through API requirements to successfully register a drug product…

CDER: Creating efficiencies in pharmaceutical development and manufacturing
04Aug

CDER: Creating efficiencies in pharmaceutical development and manufacturing

The Center for Drug Evaluation and Research (CDER) of the…

The Impact of Artificial Intelligence in the Lifecycle of Medicines
28Jul

The Impact of Artificial Intelligence in the Lifecycle of Medicines

The rapid digitalization of the biomedical and clinical research sectors…

Enhancing Accessibility to Contraceptives through Rx-to-OTC switch
25Jul

Enhancing Accessibility to Contraceptives through Rx-to-OTC switch

In a world where women’s health and autonomy are of…

The Future of Certificate of Suitability
18Jul

The Future of Certificate of Suitability

The Certificate of Suitability (CEP) to the monographs of the…

ICH: An Approach to Harmonizing Real World Data & Real World Evidence
14Jul

ICH: An Approach to Harmonizing Real World Data & Real World Evidence

The use of real-world data (RWD) and real-world evidence (RWE)…

US FDA: Resolving Disputes for Over-the-Counter Monograph Drugs
11Jul

US FDA: Resolving Disputes for Over-the-Counter Monograph Drugs

Over-The-Counter (OTC) monographs define the safety, effectiveness, and labelling of…

DDReg Exhibits at DIA Global 2023
07Jul

DDReg Exhibits at DIA Global 2023

The DIA Global Annual Meeting in 2023, which took place…

US FDA: Safety Reporting Requirements for Combination Products
05Jul

US FDA: Safety Reporting Requirements for Combination Products

In this new era, where different therapeutic realms converge, the…

Challenges in Complex Generic Drug Development
20Jun

Challenges in Complex Generic Drug Development

Complex drugs add more value to patients compared to simple…

US FDA: Keeping Up with the Momentum of Decentralized Clinical Trials
16Jun

US FDA: Keeping Up with the Momentum of Decentralized Clinical Trials

Decentralized clinical trials (DCTs) are evolving and gaining momentum within…

Evaluating PRIME: A Pathway for Innovative Medicines
14Jun

Evaluating PRIME: A Pathway for Innovative Medicines

In various therapeutic areas where life expectancy is low, delayed…

DDReg & Oktane HR – “High Impact Manager Program”
12Jun

DDReg & Oktane HR – “High Impact Manager Program”

DDReg places a strong emphasis on continuously nurturing and expanding…

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…