Publikasi

Impact of Change in Constitution of Firm on Your Licenses

Are you worried about the impact of a change in the constitution of your firm on...

The Call of India for Refurbished Medical Devices - CDS...

Refurbished medical devices are gaining traction in India as a cost-effective an...

Guidance on Loan License under D&C Act and Medical Devi...

A Loan License is a regulatory provision under the Drugs and Cosmetics Act, 1940...

The Regulatory Landscape and Future Outlook of Microflu...

Microfluidic diagnostic devices, also known as micro flow diagnostic devices, ha...

Standards and Certification: Identifying Certifiable & ...

In today's globalized and highly competitive world, standards play a crucial rol...

Usability Engineering in Medical Devices: Importance, R...

Over the past two decades, post-market surveillance has revealed concerning tren...

FDA Regulatory Pathways for LNP(Lipid Nano Particle)-Ba...

Messenger RNA (mRNA)-based therapeutics have ushered in a new era of precision m...

Risk Priority Number (RPN): A Practical Guide to Risk A...

Risk management in medical devices is a structured process that identifies, asse...

Choosing Product Development Methodologies in Regulated...

Industries like medical devices, in vitro diagnostics (IVDs), pharmaceuticals, a...

Medical Device Assessment and Approval Methods – A Study

Objective: This study compares regulatory assessment and approval methods for...

DTAB 92nd Meeting Update: No Loan License Needed for De...

India’s medical device industry is rapidly evolving, and regulatory reforms cont...

Bridging Compliance and Performance: Distinct Yet Inter...

In the regulated landscape of manufacturing—particularly in pharmaceuticals, med...

When and How the Risk-Based Approach is Applied in Qual...

In today’s regulatory landscape—especially in the medical device and life scienc...

Design & Technology Transfer Agreement – Template with ...

A Design Transfer Agreement (DTA) is a formal contract between a Licensor (techn...

Global Regulatory Writing in Medical devices: Harmoniza...

In today’s global healthcare market, a medical device is rarely sold in just one...

From Silos to Synergy: Implementing Integrated Manageme...

In a world where manufacturers juggle multiple quality, safety, and environmenta...