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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…
Medication errors: Self-medication
Florence Nightingale once said “The very first requirement in a…
Understanding the EU Clinical Trial Information System
The European Union (EU) implemented significant changes in the way…
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
Ever since the incorporation, it has been DDReg’s endeavor to…
Why is an ISO 27001 important for an organization?
In a technology driven era where businesses are increasingly incorporating…
Regulatory Information Management Systems (RIMS)
Managing regulatory information for a pharmaceutical product along all stages…
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
Drug laws & regulations in India have roots that are…
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
The pharmaceutical industry is one that is constantly growing and…
Technological transformation in Pharmacovigilance
Technological disruption is rapidly occurring across all industries. In the…
Outsourcing regulatory compliance solutions
In an era of technological advancement, and easy access to…
DDReg attends National Conference on Pharmacovigilance and Clinical Research 2022- Chandigarh College of Pharmacy
Drug abuse has gradually become an increasing issue due to…
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
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
CPhI provides a networking platform for pharmaceutical industry leaders. As…
Is QPPV training essential?
Drug safety is all about the right patient receiving the…
The impact of the Russia-Ukraine war on clinical trials
The Russia-Ukraine war has undoubtedly affected millions of people in…
The first global centre for traditional medicine: WHO Global Centre for traditional medicine in Gujurat, India
The 7th of April 2022 marked the 74th anniversary of…
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
The healthcare ecosystem is driven by several factors. Government vision,…
Biologics development & regulatory approval – EMA perspective
Biologic medicinal products, particularly biosimilars, have revolutionized the treatment of…
Biosimilarity and Interchangeability in the MENA region
A biological drug (or biologic) is one that is produced…
DDReg enters into RegTech Space
Smart regulatory processes and regulatory intelligence have evolved over past…
Biosimilars in the Emerging World
Over the last five years, biosimilars have progressively gained traction.…
African Medicines Agency
In 2019, the African Union’s Bureau of Heads of State…
Integrative Medicine
Integral health integrates traditional treatment in a coordinated way with…
Knowledge Management in Regulatory Affairs (KMRA)
Knowledge management (KM) has been a recognized discipline in other…
Telehealth – Regulatory Perspective
The COVID-19 pandemic has forced healthcare systems to drastically and quickly…
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
One of the fastest expanding technologies on the planet at…
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
The US Food and Drug Administration (FDA) has recently finalized…
Generic Drug User Fee Amendments
The US generic drug industry has grown into a major…
Impact of Brexit on the Pharmaceutical Industry
The pharmaceutical industry is one of the most important industries…
Nitrosamine Impurities: A Regulatory Perspective
In July 2018, the European medicines regulatory network became aware…