Mastodawn

drug–device combination products are more complex. The regulations are more demanding. The opportunity is bigger than ever.
#CombinationProducts #MedicalDevices #Pharma #RegulatoryStrategy #DigitalHealth #ClinicalResearch

https://genelifecr.blogspot.com/2026/05/drugdevice-combination-products.html

Drug–Device Combination Products: Revisiting the Challenges, Thirteen Years On

Drug–Device Combination Products: Challenges and Evolution in Clinical Research

Genelife Clinical Research 2d ago

In 2012, Genelife published a perspective on drug–device combination products.

The conclusion then: the benefits justify the complexity. The manufacturing model that made most sense: two distinct facilities, coordinated but separate.

Our updated perspective — what's changed, what hasn't, and what it means for your program — is now on the blog.

#DrugDeviceCombination #CombinationProducts #MedicalDevices #ClinicalResearch #RegulatoryStrategy #Pharma #DigitalHealth

https://genelifecr.blogspot.com/2026/05/drugdevice-combination-products.html

Genelife Clinical Research May 21

We reposting an article of Monday about post-marketing surveillance for biosimilars.

https://genelifecr.blogspot.com/2026/05/post-marketing-surveillance-for.html

Post-Marketing Surveillance for Biosimilars: Why Approval Is Just the Beginning

Understand the importance of pharmacovigilance and long-term safety monitoring in biosimilar development after regulatory approval.

Genelife Clinical Research May 20

Reposting our article on the #CDSCO approval process for #ClinicalTrials. As India continues to strengthen its #ClinicalResearch ecosystem, understanding the #Regulatory process is more important than ever.

https://genelifecr.blogspot.com/2026/04/cdsco-approval-process-for-clinical.html

CDSCO Approval Process for Clinical Trials in India: Complete Guide

Learn the CDSCO approval process for clinical trials in India, including regulatory steps, ethics committee approval

Genelife Clinical Research May 19

Biosimilar approval is not the finish line.
It's the point at which your pre-approval dataset — intentionally smaller than a novel biologic — meets real patients, real clinical practice, and real immune systems.

PMS isn't overhead. It's the second half of your evidence strategy.

https://genelifecr.blogspot.com/2026/05/post-marketing-surveillance-for.html

Post-Marketing Surveillance for Biosimilars: Why Approval Is Just the Beginning

Understand the importance of pharmacovigilance and long-term safety monitoring in biosimilar development after regulatory approval.

Genelife Clinical Research May 15

Reposting this article as the topic continues to remain highly relevant for sponsors planning clinical trials in India.

Selecting the right CRO can significantly influence study execution, compliance, patient recruitment, and overall development timelines.

In this article, we share practical considerations for choosing a CRO partner aligned with both scientific and operational goals.

#ClinicalResearch #CROIndia #ClinicalTrials #DrugDevelopment

https://genelifecr.blogspot.com/2026/04/how-to-choose-cro-in-india-key-factors.html

How to Choose a CRO in India: Key Factors to Consider

Learn the key factors for selecting a CRO in India for your clinical trials.

Genelife Clinical Research May 13

We published an article on Monday about India's biosimilar regulatory framework.

We are reposting the article again, in case you missed that:

https://genelifecr.blogspot.com/2026/05/biosimilar-regulation-in-india-evolving.html

Biosimilar Regulation in India: Evolving Landscape and Current Perspectives

Explore India’s evolving biosimilar regulatory framework, including CDSCO guidelines, analytical comparability, PK/PD studies, and pharmacovigilance

Genelife Clinical Research May 11

Our latest article explores the changing regulatory framework for biosimilars in India.

As the industry moves toward a more science-driven and risk-based approach, understanding the evolving biosimilar ecosystem becomes increasingly important for sponsors, researchers, and healthcare stakeholders.

https://genelifecr.blogspot.com/2026/05/biosimilar-regulation-in-india-evolving.html

Biosimilar Regulation in India: Evolving Landscape and Current Perspectives

Explore India’s evolving biosimilar regulatory framework, including CDSCO guidelines, analytical comparability, PK/PD studies, and pharmacovigilance

Genelife Clinical Research May 8

Genelife Clinical Research offers end-to-end clinical research solutions, including clinical operations, data management, regulatory affairs, and pharmacovigilance services.

Contact us today to discuss your clinical research requirements.
Visit us: https://www.genelifecr.com
#genelife #ClinicalResearch #ClinicalTrials #IndianCRO #ClinicalResearch #CRO #Pharma #DrugDevelopment

https://www.linkedin.com/pulse/clinical-trial-process-india-complete-step-by-step-guide-sponsors-ji5tf

Genelife® Clinical Research Pvt. Ltd. | CRO India

Genelife® Clinical Research is a global CRO in India offering clinical trial services for pharmaceutical, biotechnology and medical device companies.

Genelife® Clinical Research Pvt. Ltd.

Genelife Clinical Research May 7

Genelife Clinical Research offers end-to-end clinical research solutions, including clinical operations, data management, regulatory affairs, and pharmacovigilance services.

#genelife #ClinicalResearch #ClinicalTrials #IndianCRO #ClinicalResearch #CRO #Pharma #DrugDevelopment

https://www.linkedin.com/pulse/what-cro-role-clinical-research-organizations-india-genelifecr-2rhtf

What is a CRO? Role of Clinical Research Organizations in India

Introduction The journey from a promising molecule to an approved medicine can take over a decade and cost upwards of $2.6 billion.