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2 days ago8 min read
Global Drug Approval Process: Key Steps & Tips to Expedite Approval
Drugs are marketed only after their approval by regulatory authority. Only safe, effective and medicines of quality are approved by the...


2 days ago4 min read
Class III Medical Devices: Meaning, Examples, Approval Process
FDA classifies medical devices into different categories based on their risk factor. Each class of medical device holds different rules...


3 days ago4 min read
Biosimilar Product Development: Regulatory Challenges & Key Insights
In this era where the demand for affordable healthcare is increasing every day, biosimilars that are replacements for biologics have...


3 days ago9 min read
What Are IQ, OQ & PQ In Pharmaceuticals
In the pharmaceutical industry, equipment plays a vital role. So, it is compulsory to make sure that the equipment are safe, efficacious...


5 days ago8 min read
Class II Medical Devices: Meaning, Requirements, Process
Running the healthcare system without the use of medical devices is nearly impossible. Medical devices have become an integral part so...


Jan 244 min read
What Is Class I Medical Device: A Complete Guide
In the US, Center For Devices And Radiological Health (CDRH) which is a branch of FDA is the regulatory body that governs the rules and...


Jan 247 min read
Types Of Medical Devices & Medical Device Classification System
As we know, the healthcare system and medical devices are co-dependent. The safety and effectiveness of medical devices matters when they...


Jan 218 min read
Cosmetic Safety Assessment & Global Regulatory Standards
The world of cosmetics is growing rapidly. The release of a wide variety of cosmetic products into the market has happened and is...


Jan 213 min read
Regulatory Intelligence In Product Registration
Today ‘s age of AI has brought in tremendous success almost in every stream. Remarkably, AI has achieved tremendous success in the...


Jan 205 min read
Drugs vs Medicines: Understanding the Key Differences
You all might always get confused when it comes to the use of words “drugs” and “medicines”. Some people may often consider both drugs...


Jan 205 min read
What Is Certification Of Suitability (CEP) & Sister CEP Submissions?
All the regulatory documents or certifications are in place to make sure that the public/consumer health is protected. The CEP procedure...


Jan 174 min read
Pharmacovigilance System Master File (PSMF)
Pharmacovigilance (PV) is one of the most important parts of the drug product process. PV deals with the detection, assessment and...


Jan 175 min read
What Is CDSCO SUGAM & Its Registration Process
The word SUGAM means “easy to approach” in Sanskrit. Just like how it means it was developed by CDSCO to streamline the regulatory...


Jan 156 min read
Global Medical Device Regulation: Classification & Requirements
Medical devices are an unavoidable part of healthcare. Medical device development happens worldwide but not all devices are being...


Jan 154 min read
Corrective and Preventive Actions (CAPA) In Pharmaceuticals
In pharmaceuticals research, production and marketing there may be errors from the human side or due to machine error. Despite the...


Jan 155 min read
Digital Health In Regulatory Affairs
The old traditional methods of diagnosis, treatment and prevention have certain drawbacks such as late detection of non-symptomatic...


Jan 104 min read
Individual Case Safety Report (ICSR)
The pharmacovigilance sector has a great role to play in the healthcare patient protection and safety of medical products and devices....


Jan 105 min read
Drug Master File (DMF): Meaning, Submission & Guidelines
The critical information about the CMC (Chemistry, Manufacturing and Control) aspect of an active pharmaceutical ingredient or a finished...


Jan 83 min read
PADER In Pharmacovigilance: How To Prepare?
PADER (Periodic Adverse Drug Experience Report) is one of the critical components of pharmacovigilance. It is a part of the post approval...


Jan 85 min read
Pharmaceutical Excipients: Definition & Types
The main component of a drug product is the active pharmaceutical ingredient (API) but a finished drug product contains ingredients other...
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Global, Concurrent, Experience Based
Deep dive and engage in insightful discourse driven by concurrent global regulatory scenarios, industry trends and Artixio’s real-time experience across the product value chain. Whitepapers, research articles, landscape reports and case studies to help you stay ahead of the curve.
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