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Dr. Bani
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The Importance of Regulatory Compliance in Pharmacovigilance
Pharmacovigilance is crucial in the pharmaceutical industry. It ensures the safety and efficacy of drugs. This field involves monitoring,...
bani tchekanova
Oct 26, 20243 min read
Role of Clinical Regulatory Affairs in the Drug Development Process
Clinical regulatory affairs play a critical role in the drug development process by ensuring that pharmaceutical products meet regulatory...
bani tchekanova
Aug 1, 20242 min read
WHAT IS CCDS, AND WHEN IS IT NEEDED?
CCDS stands for Core Clinical Data Sheet. It is a document used in the pharmaceutical industry to provide essential information about a...
bani tchekanova
Jul 18, 20242 min read
Artificial Intelligence (AI) is revolutionizing the Pharma industry by accelerating 𝐝𝐫𝐮𝐠 𝐝𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭 𝐩𝐫𝐨𝐜𝐞𝐬𝐬𝐞𝐬.
Some of the key areas that are making development time reduction possible are: Analyzing vast datasets, improving accuracy and speed....
bani tchekanova
Jun 13, 20241 min read
Attending RAPS Regulatory Intelligence 6-7 June 2024 Conference at Maryland, USA?
Gather Your “Intelligence” for Better Regulatory Decisions. REGISTER NOW Hot Topic Sessions Include: Leveraging Collective Influence: The...
bani tchekanova
May 27, 20241 min read
Embracing Pharma 4.0: Why Pharma Executives Should Care
Credit: freepik.com In today's rapidly evolving technological landscape, the pharmaceutical industry is on the brink of a revolutionary...
bani tchekanova
May 18, 20243 min read
FDA's Implementation of Real-World Evidence in Drug Approval Processes
The FDA has launched the use of real-world evidence (RWE) in drug approval processes, marking a significant milestone in modernizing...
bani tchekanova
May 13, 20241 min read
Key Factors for Sponsors to Review When Working with CRO
When working with a (CRO), effective oversight is essential to ensure the successful conduct of the clinical trial and the quality of the...
bani tchekanova
May 10, 20242 min read
Understanding the Importance of Pre-Clinical Studies in Drug Development
The specific preclinical studies required for a new drug or biologic product can vary depending on factors such as the product's intended...
bani tchekanova
May 7, 20242 min read
Exploring the Five FDA Accelerated Programs
The FDA has several accelerated programs designed to expedite the development and review of drugs and biologics intended to treat serious...
bani tchekanova
May 3, 20242 min read
5 Major Steps of Drug Development Process
The drug development process is a complex and multi-stage journey that involves several key steps, from initial discovery to market...
bani tchekanova
Apr 30, 20242 min read
Role of Clinical Regulatory Affairs in the Drug Development Process
Clinical regulatory affairs play a critical role in the drug development process by ensuring that pharmaceutical products meet regulatory...
bani tchekanova
Apr 27, 20242 min read
Do you need to start preparing for an IND or NDA submission? or you simply need a second look at your clinical protocol?
At ClinReg Partners we partner with you to achieve your goal.
bani tchekanova
Apr 17, 20241 min read
bani tchekanova
Apr 17, 20240 min read
Join Us for an Insightful Webinar on AI and ML in Drug Development 🔍
Join Us for an Insightful Webinar on AI and ML in Drug Development 🔍 Register here: https://lnkd.in/gdkvA6P5 Curious about the...
bani tchekanova
Mar 9, 20241 min read
DATA MONITORING COMMITTEES; FDA RECENT GUIDANCE DOCUMENT, FEBRUARY 2024
AT CLINREG PARTNERS, WE WILL PARTNER WITH YOU FOR YOUR SUCCESS AND TO MAKE SURE YOU STAY INFORMED OF ALL THE NEW AND REVISED GUIDANCE...
bani tchekanova
Mar 3, 20241 min read
bani tchekanova
Feb 4, 20240 min read
Join us at the 2024 Orange County Regulatory Affairs Discussion Group Annual Meeting on May 3 in Huntington Beach, CA!
Join us at the 2024 Orange County Regulatory Affairs Discussion Group Annual Meeting on May 3 in Huntington Beach, CA! This year's...
bani tchekanova
Feb 4, 20241 min read
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