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How is EMA Addressing Medicine Shortages in Europe?
The emergence of drug shortages as a significant global health…
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
The use of artificial intelligence (AI) in the Pharmaceutical and…
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
Pharmacovigilance is paramount for the well-being of patients exposed to…
DDReg’s Diwali Celebration 2023
Diwali is a time filled with happiness, togetherness, and festivities-…
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
The OTC Health and Wellness Conference was held on the…
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
The cosmetics sector in South Korea has witnessed impressive expansion…
Pharmacovigilance in Herbal and Alternative Medicine
At the turn of the millennium, guidelines for post-marketing safety…
DDReg attends CPHI Barcelona
CPHI Barcelona was held on 24th to 26th of October…
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
Biopharmaceutical product labelling is a multifaceted undertaking that spans various…
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
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents…
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
Introduction Long-term safety, efficacy, and immunogenicity data of licensed biosimilars…
Prescription-Drug-Use-Related Software
Introduction With the advancement in digital technology, the development of…
DDReg Shortlisted for ‘Regulatory’ by CPHI Pharma Awards 2023
DDReg is thrilled to announce that it has made it…
Requesting Post-Warning Letter Meetings
During an inspection, the US FDA may detect that the…
Navigating Drug Manufacturing Inspections
The US FDA conducts drug manufacturing inspections for facilities to…
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
The UK MHRA’s Latest Update on the International Recognition Procedure…
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
Comprehending the Key Components of Formal Meetings for Biosimilar Development…
Paediatric Investigation Plan in Medicinal Product Development
Navigating the Paediatric Investigation Plan and its Significance in the…
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
Introduction Regulatory agencies require sponsors to collect and provide data…
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
Within the realm of clinical research, the process of obtaining…
Diversity Plan in Clinical Trials
The importance of recruiting diverse patients for clinical trials in…
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
Introduction Nitrosamine Drug Substance-Related Impurities (NDSRIs) share structural similarity with…
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
The Center for Drug Evaluation and Research (CDER) of the…
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
In a world where women’s health and autonomy are of…
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
The use of real-world data (RWD) and real-world evidence (RWE)…
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
The DIA Global Annual Meeting in 2023, which took place…
US FDA: Safety Reporting Requirements for Combination Products
In this new era, where different therapeutic realms converge, the…
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
Decentralized clinical trials (DCTs) are evolving and gaining momentum within…
Evaluating PRIME: A Pathway for Innovative Medicines
In various therapeutic areas where life expectancy is low, delayed…
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
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals…
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
The level of scrutiny surrounding animal medicinal products has strengthened…
Drug-Device Products: Navigating through the EU
Drug-device combination (DDC) products are increasingly demonstrating the value they…
DDReg features in BioPharma Dive
End to end global regulatory services driven through technology-enabled solutions.DDReg…
Indian Perspective on Digital Health Technology
Digital health technology has gained significant momentum in India, revolutionizing…
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
Introduction Clinical trial sponsors for pharmaceutical products (drugs and/or biologics…
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
Technological disruptors are gradually revolutionizing various aspects of life sciences…
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
The European Medicines Agency (EMA) has created a sustainable network…
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
The healthcare sector has been significantly impacted by technology, with…
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
The pharmaceutical industry including its operations and associated functions run…
Biosimilars uptake – An upward trend
The development of biologic products has increased over the last…
DDReg Exhibits at DIA Europe 2023 in Basel, Switzerland
The European Union has seen some major changes and advances…
Combination products: a regulatory perspective
Combination products are an integral part of healthcare as they…
Pre-market pathways for combination products
The regulatory landscape for combination products has been somewhat of…
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
IntroductionHereditary angioedema (HAE) is considered a rare, autosomal dominant disease…
Digitalization in Regulatory Affairs
Technology is rapidly driving the growth of the Pharmaceutical and…
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
The European regulatory system constitutes a network of pharmaceutical regulators…
We are exhibiting at DIA Europe 2023
We are exhibiting at DIA Europe 2023 Meet our experts…
Additional Risk Minimization Measures: Pregnancy Prevention Programme
IntroductionThe practice of pharmacovigilance revolves around patient safety by improving…
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
The International Conference on Harmonization of Technical Requirements for the…
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
Overview A drug is authorized by an agency only when…
Social & Digital Media Sources in Drug Safety
A crucial part of pharmacovigilance (PV) and post-market drug safety…
Challenges in ICSR processing
Individual Case Safety Reports (ICSRs) are a key aspect of…
Signal Management
A signal is information that arises from single or multiple…
Structured Product Labeling
Structured Product Labeling (SPL) was first introduced in 2006 by…
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
Medico-regulatory writing is an important part of regulatory affairs in…
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
Cell, tissue, or gene therapy products (CTGTPs) can contain non-viable…
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
The biosimilar market is rapidly growing across the globe as…
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
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
The pharmaceutical regulatory landscape in the UK has experienced many…
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
The electronic transfer of regulatory information and subsequent review of…
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
Arthritis is an inflammatory condition that affects people worldwide leading…
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
According to the World Health Organization (WHO), cardiovascular diseases (CVD)…
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
Adverse event processing & causality assessment is the preferred way…
Pharmacovigilance Services at DDReg: Our commitment towards Patient Safety
An important aspect of patient safety is Pharmacovigilance, that is…