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Data Integrity for In Vivo BABE Studies
28May

Data Integrity for In Vivo BABE Studies

The pharmaceutical industry is evolving with technological advancements with a…

Redesigned Pre-Submission Meetings for ANDAs with the US FDA
24May

Redesigned Pre-Submission Meetings for ANDAs with the US FDA

Pre ANDA meetings facilitate pre-submission communications with the US FDA…

Electronic Submissions for Investigational New Drug Safety Reports
21May

Electronic Submissions for Investigational New Drug Safety Reports

Regulatory agencies like the United States’ FDA are increasingly encouraging…

A Collaborative Approach Towards Integrating Artificial Intelligence in Medical Products
14May

A Collaborative Approach Towards Integrating Artificial Intelligence in Medical Products

Imagine a world where medical care is not just about…

Enhancing Clinical Trial Regulations for Advanced Therapy Medicinal Products
13May

Enhancing Clinical Trial Regulations for Advanced Therapy Medicinal Products

Advanced therapy medicinal products (ATMPs) including gene therapy medicinal products,…

Pharmacovigilance in New Zealand
08May

Pharmacovigilance in New Zealand

Medsafe oversees pharmaceutical product regulation in New Zealand and operates…

Designing Early-Phase Clinical Trials for Cell and Gene Therapy Products
07May

Designing Early-Phase Clinical Trials for Cell and Gene Therapy Products

Early-phase clinical trials for cell and gene therapy (CGT) products…

Navigating Orphan Drug Regulations for Gene Therapy Products
02May

Navigating Orphan Drug Regulations for Gene Therapy Products

Human gene therapy products, like other medicines, may be eligible…

DDReg Features in BioPharma Dive: At the Forefront of Biotech and Pharma
29Apr

DDReg Features in BioPharma Dive: At the Forefront of Biotech and Pharma

Join DDReg at the Biotech Beach of the world! Meet…

Conducting Clinical Trials for Investigational Products in Brazil
24Apr

Conducting Clinical Trials for Investigational Products in Brazil

Brazil is emerging as an attractive location for clinical research…

Controlled Correspondence for Generic Drug Development
22Apr

Controlled Correspondence for Generic Drug Development

Regulatory agencies across the globe are committed to ensuring that…

CMC Considerations for Human Gene Therapy INDs
18Apr

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
17Apr

Commitment to Biological Product and Patient Safety in India

Biological products are derived from living organisms or cells encompass…

Empowering Rare Disease Drug Developers
15Apr

Empowering Rare Disease Drug Developers

Advanced rare disease drug developers are companies or organizations that…

DDReg Opens Entity in Singapore
09Apr

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?
08Apr

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
01Apr

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
28Mar

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
26Mar

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
20Mar

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
18Mar

Importance of Collaboration between Global Regulators

Regulatory authorities across the globe play a pivotal role in…

DDReg Opens German Entity in Cologne (Köln)
14Mar

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
13Mar

Submitting Revised ANDA Labels to Ensure Safety & Compliance

Regulatory scrutiny for abbreviated new drug applications (ANDAs) places a…

Development of CAR T Cell Products
04Mar

Development of CAR T Cell Products

Chimeric antigen receptor (CAR) T cell products refer to therapeutic…

Model-Integrated Evidence Program for Generic Drugs
27Feb

Model-Integrated Evidence Program for Generic Drugs

Timely patient access to affordable treatment options is the goal…

Searchable Databases for Bio-Equivalence Guidance
22Feb

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
19Feb

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
14Feb

Increasing Harmonization for Complex Generics

Regulatory agencies across the globe are increasing their efforts in…

Strengthening Safety Compliance in Somalia
12Feb

Strengthening Safety Compliance in Somalia

The National Medicine Regulatory Authority (NMRA) of the Ministry of…

Ensuring Viral Safety of Biotechnology Products
08Feb

Ensuring Viral Safety of Biotechnology Products

Biotechnology products that are derived from cell lines are associated…

Regulatory Roadmap for Access to MedTech
05Feb

Regulatory Roadmap for Access to MedTech

In an era driven by technological advancements, particularly in healthcare,…

Fostering Medical Innovation with Expedited Review Processes
02Feb

Fostering Medical Innovation with Expedited Review Processes

2023 marked a significant year in the pharmaceutical industry as…

Easing Requirements for Minimal Risk Clinical Trials
29Jan

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
25Jan

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
23Jan

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
22Jan

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
18Jan

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
15Jan

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
11Jan

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
08Jan

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
05Jan

The Use of Item Response Theory in Clinical Outcome Assessments

Clinical outcome assessments (COAs) are a critical component of clinical…

Enhancing Medical Device Cybersecurity
03Jan

Enhancing Medical Device Cybersecurity

The integration of wireless, Internet, and network-connected capabilities in medical…

Utilizing Real-World Evidence for Medical Devices
02Jan

Utilizing Real-World Evidence for Medical Devices

Recent years have witnessed a surge in clinical practice data…

Quality Assurance and Compliance
27Dec

Quality Assurance and Compliance

Ensuring that products and services meet the highest standards of…

Reforming ANDA Suitability Petitions
21Dec

Reforming ANDA Suitability Petitions

Pharmaceutical companies have faced delays in receiving a response to…

Online Eligibility Checker Tool for International Recognition Procedure
19Dec

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
15Dec

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
15Dec

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
12Dec

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
07Dec

ANVISA & ANMAT: Mutual Recognition Agreement for Medical Devices

The medical device sector in Argentina and Brazil is experiencing…

Advancing Healthcare through Electronic Product Information
04Dec

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
30Nov

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?
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…