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The Value of Clinical Research Consulting Services
In today's fast-paced pharmaceutical landscape, research and development can be a daunting task. Companies face myriad challenges, from...
Dr. Bani Tcheckanoa
Jun 17, 20253 min read
Navigating Clinical Trial Regulations in the U.S.
Navigating the complex landscape of clinical trial regulations can be daunting for pharmaceutical companies and researchers....
Dr. Bani Tcheckanoa
Jun 13, 20254 min read
Regulatory Submission Management: A Comprehensive Guide
Understanding Regulatory Submission Management Regulatory submission management is a critical aspect of the pharmaceutical industry. It...
Dr. Bani Tcheckanoa
Mar 31, 20252 min read
For Emerging Biotech Firms, Understanding and Navigating the Regulatory Landscape is Crucial
Navigating the complex landscape of drug development requires a keen understanding of regulatory affairs, as these processes are critical...
Dr. Bani Tcheckanoa
Mar 15, 20252 min read
eCDT Module - 3 Key Considerations for Quality Summary
eCDT Triangle The Quality Summary in Module 3 of the electronic Common Technical Document (eCTD) provides a high-level overview of the...
Dr. Bani Tcheckanoa
Feb 19, 20252 min read
FDA Report on AI Use in Regulatory Decision-Making for Drugs and Biological Products
Overview The FDA draft guidance (January 2025) provides recommendations for the use of Artificial Intelligence (AI) in regulatory...
Dr. Bani Tcheckanoa
Feb 10, 20252 min read
Dr. Bani Tcheckanoa
Feb 9, 20250 min read
What is an IND Application?
A short introduction from Dr. Bani, Chief Principal Advisor in Global Clinical Regulatory Affairs at ClinReg Partners. Book your...
Dr. Bani Tcheckanoa
Jan 25, 20251 min read
How Soon Should I get Regulatory Team Involved in Drug Development process ?
A short introduction from Dr. Bani, Chief Principal Advisor in Global Clinical Regulatory Affairs at ClinReg Partners. Book your...
Dr. Bani Tcheckanoa
Jan 23, 20251 min read
What is Clinical Regulatory Affairs?
A short introduction from Dr. Bani, Chief Principal Advisor in Global Clinical Regulatory Affairs at ClinReg Partners. Book your...
Dr. Bani Tcheckanoa
Jan 21, 20251 min read
Navigating the Challenges of eCTD Submissions: What to Look For and How to Overcome Pitfalls
The Electronic Common Technical Document (eCTD) submission process is crucial in the regulatory framework. It facilitates the seamless...
Dr. Bani Tcheckanoa
Dec 26, 20243 min read
Introducing Dr. Bani Tchekanova's Latest eBook: Top 10 Strategies to Overcome Challenges in Drug Development
In the high-stakes journey of bringing a drug to market, some executives may overlook critical elements that determine success. Dr....
Dr. Bani Tcheckanoa
Dec 17, 20241 min read
Top 10 Pharma Industry Trends & Innovations for 2025
The pharmaceutical industry is evolving rapidly, driven by technology, regulatory changes, and new patient needs. Here’s a snapshot of...
Dr. Bani Tcheckanoa
Dec 4, 20242 min read
10 Essential Steps for a Successful FDA Meeting in your drug development journey
Introduction The FDA meeting process is a critical milestone in drug development, offering opportunities to gain regulatory alignment and...
Dr. Bani Tcheckanoa
Nov 26, 20242 min read
Top 5 Areas to Leverage Expert Clinical Regulatory Affairs Advisor for New Drug Development Companies
Accelerate Your Path to Market with ClinReg Partners At ClinReg Partners, we specialize in guiding emerging pharmaceutical and biotech...
Dr. Bani Tcheckanoa
Nov 25, 20242 min read
eCTD Consultation and Submission Services for FDA Compliance
eCTD Consultation and Submission Services for FDA Compliance Streamlining Your Path to Regulatory Approval At ClinReg Partners, we...
Dr. Bani Tcheckanoa
Nov 23, 20242 min read
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,...
Dr. Bani Tcheckanoa
Oct 26, 20243 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...
Dr. Bani Tcheckanoa
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....
Dr. Bani Tcheckanoa
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...
Dr. Bani Tcheckanoa
May 27, 20241 min read
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