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
Biological products are derived from living organisms or cells encompass…
Empowering Rare Disease Drug Developers
Advanced rare disease drug developers are companies or organizations that…
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?
In the development of the UK’s medical device industry, a…
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
With the expansion of clinical research and development, precise labeling…
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
In the realm of healthcare, patients have a fundamental right…
Importance of Collaboration between Global Regulators
Regulatory authorities across the globe play a pivotal role in…
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
Regulatory scrutiny for abbreviated new drug applications (ANDAs) places a…
Development of CAR T Cell Products
Chimeric antigen receptor (CAR) T cell products refer to therapeutic…
Model-Integrated Evidence Program for Generic Drugs
Timely patient access to affordable treatment options is the goal…
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
The field of gene therapy has witnessed significant advancements with…
Increasing Harmonization for Complex Generics
Regulatory agencies across the globe are increasing their efforts in…
Strengthening Safety Compliance in Somalia
The National Medicine Regulatory Authority (NMRA) of the Ministry of…
Ensuring Viral Safety of Biotechnology Products
Biotechnology products that are derived from cell lines are associated…
Regulatory Roadmap for Access to MedTech
In an era driven by technological advancements, particularly in healthcare,…
Fostering Medical Innovation with Expedited Review Processes
2023 marked a significant year in the pharmaceutical industry as…
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
Real world data (RWD) is proving to be an important…
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
The 4th edition of the Economic Times (ET) RE Pharma…
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
Efficiently detecting safety signals for veterinary products is crucial for…
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
Pharmacovigilance in India has come a long way over the…
The Use of Item Response Theory in Clinical Outcome Assessments
Clinical outcome assessments (COAs) are a critical component of clinical…
Enhancing Medical Device Cybersecurity
The integration of wireless, Internet, and network-connected capabilities in medical…
Utilizing Real-World Evidence for Medical Devices
Recent years have witnessed a surge in clinical practice data…
Quality Assurance and Compliance
Ensuring that products and services meet the highest standards of…
Reforming ANDA Suitability Petitions
Pharmaceutical companies have faced delays in receiving a response to…
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
Regulatory policies that govern generic drug applications, like the Abbreviated…
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
The importance of aligning pharmaceutical regulations in the development process…
ANVISA & ANMAT: Mutual Recognition Agreement for Medical Devices
The medical device sector in Argentina and Brazil is experiencing…
Advancing Healthcare through Electronic Product Information
Electronic Product Information (ePI) is authorized, statutory information for medicines,…
DDReg Participates in India Pharma Awards 2023 for Excellence in Ancillary Pharma Services
DDReg participated in the 10th edition of the prestigious India…
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…