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Pharmacovigilance In Clinical Trials
Clinical trials are an integral part in the development of medical products. It is done to ensure that the product under development will...
Mar 209 min read
Class II & III Medical Device Registration in Indonesia
Every country has its rules and regulations for medical devices, which must be followed to bring the medical device to the market of the...
Mar 183 min read
Computer System Validation (CSV) in Pharma: Guidelines & Best Practices
Computer systems are widely used in the pharmaceutical industry. With an increase in the use of computer systems in regulated industries,...
Feb 1710 min read
503A vs 503B Compounding Pharmacies: Key Differences Explained
Compounding pharmacies aim to provide tailored medications according to the patient's prescriptions. Hence, compounding pharmacies play...
Feb 135 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...
Jan 308 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...
Jan 304 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...
Jan 294 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...
Jan 299 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 278 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 244 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 247 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 218 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 213 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 205 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 174 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 175 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 156 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 154 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 155 min read
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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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