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7 hours ago8 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...
8 hours ago3 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...
1 day ago5 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...
1 day ago5 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...
4 days ago4 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...
4 days ago5 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...
6 days ago6 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...
6 days ago4 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...
6 days ago5 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...
Jan 74 min read
What Is Structured Product Labeling (SPL)?
Structured Product Labeling format is used to submit the labeling content in electronic format. It is a standard document used to...
Jan 64 min read
What Is CCDS?
The label of a pharmaceutical product is of great importance and allows for its safe and effective use. Speaking of CCDS, it is a master...
Jan 65 min read
Post-Market Surveillance In Medical Device Regulation
One of the biggest accomplishments in the journey of a drug product is its entry into the market as a commercialized product. But the...
Jan 34 min read
IND Vs NDA In Pharmacy (Key Differences)
IND and NDA are the crucial components of the navigation guide for the journey of new drug development. IND stands for “Investigational...
Jan 26 min read
Nutraceutical Labelling Compliance In India
Food adulteration has led to many deficiencies in the human body. This has led to the emergence of nutraceuticals or dietary supplements,...
Jan 25 min read
eCTD Structure & Submission Process
Common Technical Document (CTD) is a common standard format for submitting regulatory documents to the respective regulatory authorities...
Dec 27, 20246 min read
New Drug Application Meaning & Approval Process
NDA plays a very crucial role in the drug approval process. The regulation and control of new drugs in the United States has been based...
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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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